Veranstaltungsübersicht - Pharma & Healthcare April 2021 bis Juni 2021 - FORUM Institut
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Veranstaltungsübersicht April 2021 bis Juni 2021 Pharma & Healthcare
Inhaltsverzeichnis
Forschung & Klinische Forschung
1
Qualitätsmanagement in der Klinischen Forschung ............................................................................................................................................................................................................
Registerstudien ............................................................................................................................................................................................................ 1
1
Best practice: Post-Authorisation Safety Studies (PASS) ............................................................................................................................................................................................................
1
GCP-Audits: Data Management im Fokus ............................................................................................................................................................................................................
2
Klinische Bewertungen bei Medizinprodukten richtig erstellen! ............................................................................................................................................................................................................
2
Pharmakokinetik & PK/PD-Modellierung ............................................................................................................................................................................................................
2
Kompaktwissen Klinische Prüfpräparate ............................................................................................................................................................................................................
Einsteigerwissen Onkologie ............................................................................................................................................................................................................ 3
3
Klinische Prüfungen erfolgreich auditieren ............................................................................................................................................................................................................
3
Validierung von IT-Systemen in der Klinischen Forschung ............................................................................................................................................................................................................
3
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
PMS/PMCF ............................................................................................................................................................................................................ 4
4
Das neue Monitoring-Konzept für klinische Prüfungen ............................................................................................................................................................................................................
4
Tag der Klinischen Forschung 2021 ............................................................................................................................................................................................................
4
Publikationen klinischer Arzneimittelstudien richtig bewerten ............................................................................................................................................................................................................
5
Statistik für Medizinprodukte-Studien ............................................................................................................................................................................................................
5
How CORONA has changed the regulatory affairs world ............................................................................................................................................................................................................
Fachwissen Pharma ............................................................................................................................................................................................................ 5
5
Fundraising in medizinischen Einrichtungen ............................................................................................................................................................................................................
Präklinik kompakt ............................................................................................................................................................................................................ 6
6
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
6
Risikobasiertes Auditmanagement ............................................................................................................................................................................................................
6
Medizin- und Pharmainformationen recherchieren! ............................................................................................................................................................................................................
7
Studiendaten in wissenschaftlicher Information und Werbung ............................................................................................................................................................................................................
7
Good Clinical Laboratory Practice (GCLP) ............................................................................................................................................................................................................
7
Verträge im Rahmen klinischer Prüfungen ............................................................................................................................................................................................................
7
Projektmanagement in klinischen Prüfungen ............................................................................................................................................................................................................
8
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................
8
MedDRA: Das volle Potenzial ausschöpfen ............................................................................................................................................................................................................
Integrated Product Development ............................................................................................................................................................................................................8
8
IMPD: Anforderungen an CMC-Daten ............................................................................................................................................................................................................
9
Trial Master File und Investigator Site File ............................................................................................................................................................................................................
Regulatory Affairs
10
Die Assistenz in der Zulassungsabteilung ............................................................................................................................................................................................................
EU-Zulassung für Einsteiger ............................................................................................................................................................................................................ 10
10
Die Risikomanagement-Akte von Medizinprodukten ............................................................................................................................................................................................................
11
Vendor Oversight in the Pharma Industry ............................................................................................................................................................................................................
11
Market Access Orphan drugs - Germany and the EU5 ............................................................................................................................................................................................................
11
Die Technische Dokumentation für Medizinprodukte ............................................................................................................................................................................................................
11
Master Class - Informationsbeauftragter ............................................................................................................................................................................................................
12
Der CMC-Manager in Regulatory Affairs ............................................................................................................................................................................................................
Medical Devices in APAC ............................................................................................................................................................................................................ 12
12
Klinische Bewertungen bei Medizinprodukten richtig erstellen! ............................................................................................................................................................................................................
13
Regulatory Affairs-Workshop für Fortgeschrittene ............................................................................................................................................................................................................
13
Beratung vor und im AMNOG-Verfahren ............................................................................................................................................................................................................
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 13eSubmission - Ihre To-dos 2021 ............................................................................................................................................................................................................ 13
PMS/PMCF ............................................................................................................................................................................................................ 14
14
Zulassungspflege und Lifecycle-Management ............................................................................................................................................................................................................
CMC für Biologicals ............................................................................................................................................................................................................ 14
14
Evidenzgenerierung mit digitalen Lösungen ............................................................................................................................................................................................................
Artwork Management ............................................................................................................................................................................................................ 15
15
Qualitäts- und GMP-Know-how für Regulatory Affairs/CMC ............................................................................................................................................................................................................
15
How CORONA has changed the regulatory affairs world ............................................................................................................................................................................................................
Fachwissen Pharma ............................................................................................................................................................................................................ 15
16
Marketing authorisation & lifecycle management ............................................................................................................................................................................................................
16
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
16
Produktinformationstexte auf dem aktuellsten Stand halten ............................................................................................................................................................................................................
16
Labelling, UDI & Produktinformationen ............................................................................................................................................................................................................
17
Medizin- und Pharmainformationen recherchieren! ............................................................................................................................................................................................................
17
Regulatory Affairs, CMC and GMP in Russia ............................................................................................................................................................................................................
17
Reklamationsmanagement bei Medizinprodukten ............................................................................................................................................................................................................
17
Parallelhandel von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
18
Dezentrale Verfahren und nationale Besonderheiten ............................................................................................................................................................................................................
18
Global Medical Devices Registrations ............................................................................................................................................................................................................
18
Aufbauwissen für den Informationsbeauftragten ............................................................................................................................................................................................................
Der Regulatory Affairs Manager ............................................................................................................................................................................................................ 18
19
Outsourcing & Oversight an der Schnittstelle Regulatory Affairs, Pharmacovigilance & Quality ..................................................................................................................................................................
19
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................
Integrated Product Development ............................................................................................................................................................................................................19
19
IMPD: Anforderungen an CMC-Daten ............................................................................................................................................................................................................
20
Der CMC-Manager in Regulatory Affairs ............................................................................................................................................................................................................
Pharmakovigilanz
21
Pharmacovigilance Inspection Readiness ............................................................................................................................................................................................................
21
Safety & Information Handling in Market Research & Patient Support ........................................................................................................................................................................................................
Basiswissen Pharmakovigilanz ............................................................................................................................................................................................................ 21
21
Datenschutz in der Pharmakovigilanz ............................................................................................................................................................................................................
22
Vendor Oversight in the Pharma Industry ............................................................................................................................................................................................................
22
Best practice: Post-Authorisation Safety Studies (PASS) ............................................................................................................................................................................................................
Drug Safety in der digitalen Welt ............................................................................................................................................................................................................22
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 22
23
HOT TOPICS in der Pharmakovigilanz ............................................................................................................................................................................................................
23
Ready, steady, go -Pharmacovigilance preparations for a successful product launch ..................................................................................................................................................................................
23
Qualitätsmängel und die Auswirkungen auf die Pharmakovigilanz ............................................................................................................................................................................................................
PMS/PMCF ............................................................................................................................................................................................................ 23
24
Pharmakovigilanz-Verträge advanced ............................................................................................................................................................................................................
24
Qualitätsmanagement in der Pharmakovigilanz ............................................................................................................................................................................................................
24
Pharmacovigilance Requirements in Emerging Markets ............................................................................................................................................................................................................
Fachwissen Pharma ............................................................................................................................................................................................................ 24
25
Medical Writing in Pharmacovigilance ............................................................................................................................................................................................................
25
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
25
PRRC: Die Verantwortliche Person für Regulatory Compliance ............................................................................................................................................................................................................
25
Medizin- und Pharmainformationen recherchieren! ............................................................................................................................................................................................................
26
Umgang mit Literaturdaten in der Pharmakovigilanz ............................................................................................................................................................................................................
26
Parallelhandel von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
26
Krisenkommunikation in Pharma und Healthcare: Ihre To Dos ............................................................................................................................................................................................................26
Aufbauwissen für den Informationsbeauftragten ............................................................................................................................................................................................................
27
Ausbildung zum Drug Safety Manager ............................................................................................................................................................................................................
27
MedDRA: Das volle Potenzial ausschöpfen ............................................................................................................................................................................................................
QS, Produktion & Logistik
28
Die Risikomanagement-Akte von Medizinprodukten ............................................................................................................................................................................................................
28
Die Technische Dokumentation für Medizinprodukte ............................................................................................................................................................................................................
Großhandelsbeauftragte ............................................................................................................................................................................................................ 28
28
Praxis-Know-how Selbstinspektionen/internes Audit ............................................................................................................................................................................................................
29
Leiter QK/QA und QP: Aufgaben, Pflichten und Verantwortung ............................................................................................................................................................................................................
GMP-/GDP-Auditor ............................................................................................................................................................................................................ 29
29
Der CMC-Manager in Regulatory Affairs ............................................................................................................................................................................................................
30
Handel, Vertrieb und Import von Medizinprodukten ............................................................................................................................................................................................................
GMP-/GDP-Auditor ............................................................................................................................................................................................................ 30
30
Kompaktwissen Klinische Prüfpräparate ............................................................................................................................................................................................................
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 30
31
GxP in der Cloud: Löst Outsourcing alle Probleme der Pharmaindustrie? ....................................................................................................................................................................................................
31
Quality Assurance meets Logistics ............................................................................................................................................................................................................
Lohnherstellungs-Verträge ............................................................................................................................................................................................................ 31
31
Qualitätsmängel und die Auswirkungen auf die Pharmakovigilanz ............................................................................................................................................................................................................
32
Arzneimittelversorgung & Lieferengpässe ............................................................................................................................................................................................................
CMC für Biologicals ............................................................................................................................................................................................................ 32
Datenintegrität im GxP-Bereich ............................................................................................................................................................................................................ 32
Good Distribution Practice ............................................................................................................................................................................................................ 32
Artwork Management ............................................................................................................................................................................................................ 33
33
Hot Topics Related to Quality in Herbal Medicinal Products ............................................................................................................................................................................................................
33
Qualitäts- und GMP-Know-how für Regulatory Affairs/CMC ............................................................................................................................................................................................................
33
Remote-Audits/Inspektionen in GMP/GDP ............................................................................................................................................................................................................
Präklinik kompakt ............................................................................................................................................................................................................ 34
34
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
34
Produktinformationstexte auf dem aktuellsten Stand halten ............................................................................................................................................................................................................
34
Aufbauwissen für den Großhandelsbeauftragten ............................................................................................................................................................................................................
35
Labelling, UDI & Produktinformationen ............................................................................................................................................................................................................
35
Data integrity & Audit Trail Review in pharmaceutical production ............................................................................................................................................................................................................
35
Regulatory Affairs, CMC and GMP in Russia ............................................................................................................................................................................................................
35
Reklamationsmanagement bei Medizinprodukten ............................................................................................................................................................................................................
36
Parallelhandel von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
36
Krisenkommunikation in Pharma und Healthcare: Ihre To Dos ............................................................................................................................................................................................................
36
Outsourcing & Oversight an der Schnittstelle Regulatory Affairs, Pharmacovigilance & Quality ..................................................................................................................................................................
Integrated Product Development ............................................................................................................................................................................................................36
37
Der CMC-Manager in Regulatory Affairs ............................................................................................................................................................................................................
Medical Affairs
38
Safety & Information Handling in Market Research & Patient Support ........................................................................................................................................................................................................
38
Master Class - Informationsbeauftragter ............................................................................................................................................................................................................
38
Pharma Digital & Social Media Marketing Manager ............................................................................................................................................................................................................
Praxistraining Medical Advisor ............................................................................................................................................................................................................ 38
39
Klinische Bewertungen bei Medizinprodukten richtig erstellen! ............................................................................................................................................................................................................
Medical Information Lehrgang ............................................................................................................................................................................................................ 39Der Informationsbeauftragte ............................................................................................................................................................................................................ 39
Online-Content für Ärzte ............................................................................................................................................................................................................ 39
Aufbauwissen für MSL ............................................................................................................................................................................................................ 40
Pharma Pre-Launch ............................................................................................................................................................................................................ 40
40
Rechtssicherheit bei medizinisch-wissenschaftlichen Anfragen ............................................................................................................................................................................................................
40
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
41
Evidenzgenerierung mit digitalen Lösungen ............................................................................................................................................................................................................
41
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
41
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
41
Medizin- und Pharmainformationen recherchieren! ............................................................................................................................................................................................................
42
Studiendaten in wissenschaftlicher Information und Werbung ............................................................................................................................................................................................................
42
Werbeaussagen absichern & verteidigen ............................................................................................................................................................................................................
42
Aufbauwissen für den Informationsbeauftragten ............................................................................................................................................................................................................
42
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................
43
Prozesse und SOPs in Medical Information ............................................................................................................................................................................................................
Werbung, Marketing & Vertrieb
44
Safety & Information Handling in Market Research & Patient Support ........................................................................................................................................................................................................
44
Kennzeichnung, Verpackung und Marketing von Kosmetika ............................................................................................................................................................................................................
44
Preisbildung und Abrechnung von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
Großhandelsbeauftragte ............................................................................................................................................................................................................ 45
45
Master Class - Informationsbeauftragter ............................................................................................................................................................................................................
Drug Safety in der digitalen Welt ............................................................................................................................................................................................................45
45
Pharma Digital & Social Media Marketing Manager ............................................................................................................................................................................................................
46
Handel, Vertrieb und Import von Medizinprodukten ............................................................................................................................................................................................................
Medical Devices in APAC ............................................................................................................................................................................................................ 46
Der Informationsbeauftragte ............................................................................................................................................................................................................ 46
Online-Content für Ärzte ............................................................................................................................................................................................................ 46
Einsteigerwissen Onkologie ............................................................................................................................................................................................................ 47
47
Pricing in Europa: Systeme und Strategien ............................................................................................................................................................................................................
47
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Aufbauwissen für MSL ............................................................................................................................................................................................................ 47
48
Content Marketing im Healthcare Bereich ............................................................................................................................................................................................................
Pharma Pre-Launch ............................................................................................................................................................................................................ 48
48
Zulassungs- und Produktkauf im Pharma-Bereich ............................................................................................................................................................................................................
48
Rechtssicherheit bei medizinisch-wissenschaftlichen Anfragen ............................................................................................................................................................................................................
49
Online-Vertrieb von OTC-Arzneimitteln ............................................................................................................................................................................................................
49
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
49
Evidenzgenerierung mit digitalen Lösungen ............................................................................................................................................................................................................
Good Distribution Practice ............................................................................................................................................................................................................ 49
50
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
Fachwissen Pharma ............................................................................................................................................................................................................ 50
50
Fundraising in medizinischen Einrichtungen ............................................................................................................................................................................................................
Pharma Tendermanager ............................................................................................................................................................................................................ 50
51
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
51
Studiendaten in wissenschaftlicher Information und Werbung ............................................................................................................................................................................................................
51
Werbeaussagen absichern & verteidigen ............................................................................................................................................................................................................
51
Naturprodukte: Kosmetika, Nahrungsergänzungsmittel oder Arzneimittel .................................................................................................................................................................................................
52
Parallelhandel von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
52
Krisenkommunikation in Pharma und Healthcare: Ihre To Dos ............................................................................................................................................................................................................
52
Key Account Kassenärztliche Vereinigung ............................................................................................................................................................................................................52
Pharma Key Account Management Konzepte ............................................................................................................................................................................................................
53
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................
53
Prozesse und SOPs in Medical Information ............................................................................................................................................................................................................
Gesundheitspolitik & Market Access
54
Preisbildung und Abrechnung von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
54
Market Access Orphan drugs - Germany and the EU5 ............................................................................................................................................................................................................
Verträge mit Krankenkassen 2021 ............................................................................................................................................................................................................54
55
Beratung vor und im AMNOG-Verfahren ............................................................................................................................................................................................................
55
Pricing in Europa: Systeme und Strategien ............................................................................................................................................................................................................
55
Datenanforderungen & Statistik für das Nutzendossier ............................................................................................................................................................................................................
Pharma Pre-Launch ............................................................................................................................................................................................................ 55
56
Arzneimittelversorgung & Lieferengpässe ............................................................................................................................................................................................................
56
Zulassungs- und Produktkauf im Pharma-Bereich ............................................................................................................................................................................................................
56
Evidenzgenerierung mit digitalen Lösungen ............................................................................................................................................................................................................
56
Verstehen Sie das deutsche Gesundheitssystem? ............................................................................................................................................................................................................
57
Digitalisierung im Arzt- und Apothekenumfeld - Ausblick auf die nächste Legislaturperiode ......................................................................................................................................................................
Das AMNOG-Seminar ............................................................................................................................................................................................................ 57
Pharma Tendermanager ............................................................................................................................................................................................................ 57
57
Generika: Pricing und Rabattverträge ............................................................................................................................................................................................................
58
Key Account Kassenärztliche Vereinigung ............................................................................................................................................................................................................
58
Pharma Key Account Management Konzepte ............................................................................................................................................................................................................
58
Workshop Krankenkassenkooperationen ............................................................................................................................................................................................................
58
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................
Pharmarecht
59
Ausbildung zum Pharma Legal Counsel ............................................................................................................................................................................................................
59
Preisbildung und Abrechnung von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
59
Futtermittel, Zusatzstoff, Arzneimittel: Abgrenzung, Zulassung & Kennzeichnung ......................................................................................................................................................................................
59
Datenschutz in der Pharmakovigilanz ............................................................................................................................................................................................................
Großhandelsbeauftragte ............................................................................................................................................................................................................ 60
Verträge mit Krankenkassen 2021 ............................................................................................................................................................................................................60
Der Informationsbeauftragte ............................................................................................................................................................................................................ 60
Online-Content für Ärzte ............................................................................................................................................................................................................ 60
61
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Lohnherstellungs-Verträge ............................................................................................................................................................................................................ 61
Das neue MPDG ............................................................................................................................................................................................................ 61
61
Zulassungs- und Produktkauf im Pharma-Bereich ............................................................................................................................................................................................................
62
Rechtssicherheit bei medizinisch-wissenschaftlichen Anfragen ............................................................................................................................................................................................................
62
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
62
Pharmakovigilanz-Verträge advanced ............................................................................................................................................................................................................
62
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
Pharma Tendermanager ............................................................................................................................................................................................................ 63
63
Medizinprodukte-Crashkurs für die Pharmabranche ............................................................................................................................................................................................................
63
Werbeaussagen absichern & verteidigen ............................................................................................................................................................................................................
63
Naturprodukte: Kosmetika, Nahrungsergänzungsmittel oder Arzneimittel .................................................................................................................................................................................................
64
Parallelhandel von Arzneimitteln in Deutschland ............................................................................................................................................................................................................
64
Verträge im Rahmen klinischer Prüfungen ............................................................................................................................................................................................................
64
ePA, Medical Apps & Co. - Rechtsfragen und Datenschutz ............................................................................................................................................................................................................Sie können auch lesen
