Veranstaltungsübersicht - Pharma & Healthcare Juli bis September 2021 - FORUM Institut
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Veranstaltungsübersicht Juli bis September 2021 Pharma & Healthcare
Inhaltsverzeichnis
Forschung & Klinische Forschung
SOPs in der Klinischen Forschung ............................................................................................................................................................................................................1
1
Update: Methodenvalidierung & Transfer analytischer Methoden ............................................................................................................................................................................................................
1
Archivierung klinischer Studiendokumentation ............................................................................................................................................................................................................
1
Die Klinische Prüfung nach AMG & ICH GCP ............................................................................................................................................................................................................
2
Klinische Prüfung von Medizinprodukten 2021 ............................................................................................................................................................................................................
CDISC ............................................................................................................................................................................................................ 2
Biotech-Arzneimittel ............................................................................................................................................................................................................ 2
3
Basiswissen Statistik klinischer Prüfungen ............................................................................................................................................................................................................
Kompaktwissen Onkologie ............................................................................................................................................................................................................ 3
3
Arzneimittelsicherheit in klinischen Prüfungen ............................................................................................................................................................................................................
3
IITs und sonstige klinische Prüfungen mit Medizinprodukten ............................................................................................................................................................................................................
4
On-site Monitoring klinischer Prüfungen ............................................................................................................................................................................................................
Remote Audits im GCP-Bereich ............................................................................................................................................................................................................ 4
Toxicology Summer School ............................................................................................................................................................................................................ 4
Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 4
Analytik kompakt für CMC ............................................................................................................................................................................................................ 5
5
Successful Medical and Scientific Writing ............................................................................................................................................................................................................
5
Qualitätsmanagement gemäß ICH GCP in kleinen Organisationseinheiten .................................................................................................................................................................................................
5
Prüfplanentwicklung in klinischen Prüfungen ............................................................................................................................................................................................................
6
Kompaktwissen Klinische Prüfung ............................................................................................................................................................................................................
6
Klinische Prüfungen erfolgreich auditieren ............................................................................................................................................................................................................
6
Praxistraining Clinical Data Management ............................................................................................................................................................................................................
6
Qualitätsmanagement in der Klinischen Forschung ............................................................................................................................................................................................................
All about ATMP ............................................................................................................................................................................................................ 7
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 7
7
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Zollrecht für Entscheider ............................................................................................................................................................................................................ 7
8
Trial Master File und Investigator Site File ............................................................................................................................................................................................................
Regulatory Affairs
9
Regulatory Data & Regulatory Operation ............................................................................................................................................................................................................
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 9
9
Improve your Regulatory Intelligence (RI) Skills ............................................................................................................................................................................................................
9
Medical Devices in Russia and the Eurasian Union ............................................................................................................................................................................................................
10
Phytopharmaka & Homöopathika: Regulatory-Affairs-Essentials ............................................................................................................................................................................................................
Qualitätsbedingte Variations ............................................................................................................................................................................................................ 10
10
Vom PV-Signal zum Labeling Change ............................................................................................................................................................................................................
10
Freigabe von Produktinformationstexten und Educational Material ............................................................................................................................................................................................................
11
Arzneimittelzulassung für Einsteiger ............................................................................................................................................................................................................
11
Prozessvalidierung - Anforderungen an CMC-Daten ............................................................................................................................................................................................................
Analytik kompakt für CMC ............................................................................................................................................................................................................ 11
11
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
12
Labelling Management & Artwork ............................................................................................................................................................................................................
12
Kombinationsprodukte - neue Anforderungen an bestehende und neue Zulassungen ................................................................................................................................................................................
12
Marketing Authorisation in Latin America ............................................................................................................................................................................................................
12
Regulatory Affairs für Assistenzen/Associates ............................................................................................................................................................................................................
Zulassung von Tierarzneimitteln ............................................................................................................................................................................................................1313
CMC requirements in Latin America ............................................................................................................................................................................................................
13
EU Regulatory Affairs introductory training course ............................................................................................................................................................................................................
All about ATMP ............................................................................................................................................................................................................ 13
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 14
14
CTD: CMC-Daten aufbereiten und aktuell halten ............................................................................................................................................................................................................
14
Scientific ENGLISH Writing and Reviewing in Regulatory Affairs ............................................................................................................................................................................................................
Annual CMC Conference ............................................................................................................................................................................................................ 15
Pharmakovigilanz
GVP-Auditor ............................................................................................................................................................................................................ 16
16
Der Stufenplanbeauftragte/die Qualified Person for Pharmacovigilance .....................................................................................................................................................................................................
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 16
Kompaktwissen Onkologie ............................................................................................................................................................................................................ 17
17
Arzneimittelsicherheit in klinischen Prüfungen ............................................................................................................................................................................................................
17
Vom PV-Signal zum Labeling Change ............................................................................................................................................................................................................
17
Freigabe von Produktinformationstexten und Educational Material ............................................................................................................................................................................................................
Praxisworkshop GDP ............................................................................................................................................................................................................ 18
Pharmakovigilanz in der Affiliate ............................................................................................................................................................................................................18
18
Pharmakovigilanz-Trainings: Planung & Durchführung ............................................................................................................................................................................................................
18
Risk based Pharmacovigilance audits ............................................................................................................................................................................................................
19
Erfolgreiches Benefit-Risk Assessment in der Pharmakovigilanz ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 19
19
Das 1x1 der Arzneimittelsicherheit ............................................................................................................................................................................................................
QS, Produktion & Logistik
Der Leiter der Herstellung ............................................................................................................................................................................................................ 20
20
Update: Methodenvalidierung & Transfer analytischer Methoden ............................................................................................................................................................................................................
20
Effizientes Reklamationsmanagement im GMP-Umfeld ............................................................................................................................................................................................................
GVP-Auditor ............................................................................................................................................................................................................ 20
Standortbestimmung Cannabis ............................................................................................................................................................................................................ 21
Biotech-Arzneimittel ............................................................................................................................................................................................................ 21
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 21
GDP für Tierarzneimittel ............................................................................................................................................................................................................ 22
Qualitätsbedingte Variations ............................................................................................................................................................................................................ 22
22
MASTER CLASS Großhandelsbeauftragter ............................................................................................................................................................................................................
Praxisworkshop GDP ............................................................................................................................................................................................................ 22
23
Prozessvalidierung - Anforderungen an CMC-Daten ............................................................................................................................................................................................................
Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 23
23
GMP-kompakt für das Back Office ............................................................................................................................................................................................................
Analytik kompakt für CMC ............................................................................................................................................................................................................ 23
Betäubungsmittel-Workshop ............................................................................................................................................................................................................ 23
Großhandelsbeauftragte ............................................................................................................................................................................................................ 24
Betäubungsmittel ............................................................................................................................................................................................................ 24
24
GMP-Essentials im Qualitätsmanagement ............................................................................................................................................................................................................
24
Regulatory Compliance und Change Control bei Medizinprodukten ............................................................................................................................................................................................................
25
CMC requirements in Latin America ............................................................................................................................................................................................................
25
Herstellung steriler Arzneimittel - die Neufassung des Annex 1 ............................................................................................................................................................................................................
Die Sachkundige Person ............................................................................................................................................................................................................ 25
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 2526
CTD: CMC-Daten aufbereiten und aktuell halten ............................................................................................................................................................................................................
26
Reinigungsvalidierung in der pharmazeutischen Herstellung ............................................................................................................................................................................................................
Zollrecht für Entscheider ............................................................................................................................................................................................................ 26
Annual CMC Conference ............................................................................................................................................................................................................ 27
Medical Affairs
28
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
28
Sommerspecial Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
28
Statistikwissen und Studieninterpretation ............................................................................................................................................................................................................
Der Medical Manager ............................................................................................................................................................................................................ 28
Fortbildungen für Ärzte ............................................................................................................................................................................................................ 29
29
Freigabe von Produktinformationstexten und Educational Material ............................................................................................................................................................................................................
29
Healthcare Management & Market Access-Lehrgang ............................................................................................................................................................................................................
29
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
Kommunikationstraining für MSL ............................................................................................................................................................................................................30
Pharma-Marketing-Diplom ............................................................................................................................................................................................................ 30
Rechtssicheres Pre-Marketing ............................................................................................................................................................................................................ 30
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 30
31
Informationsbeauftragter - Sommerakademie ............................................................................................................................................................................................................
Patient Support Programme ............................................................................................................................................................................................................ 31
Werbung, Marketing & Vertrieb
Standortbestimmung Cannabis ............................................................................................................................................................................................................ 32
32
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
32
Sommerspecial Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
33
8. Pharma Multichannel Management Tagung ............................................................................................................................................................................................................
Der Medical Manager ............................................................................................................................................................................................................ 33
OTC - Marketing & Vertrieb ............................................................................................................................................................................................................ 33
Fortbildungen für Ärzte ............................................................................................................................................................................................................ 34
Der Medizinprodukte-Handel ............................................................................................................................................................................................................ 34
Pharma-Vertrieb im New Normal ............................................................................................................................................................................................................34
34
Key Account Management im regionalen Market Access ............................................................................................................................................................................................................
Großhandelsbeauftragte ............................................................................................................................................................................................................ 35
35
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
Pharma-Marketing-Diplom ............................................................................................................................................................................................................ 35
35
Lizenzierung, Zulassungs- und Produktkauf ............................................................................................................................................................................................................
Rechtssicheres Pre-Marketing ............................................................................................................................................................................................................ 36
36
Market Access ATMP/Gentherapeutika ............................................................................................................................................................................................................
36
Pharma-Key-Account-Management ............................................................................................................................................................................................................
36
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 37
37
Crashkurs Pharma Business Development ............................................................................................................................................................................................................
37
Informationsbeauftragter - Sommerakademie ............................................................................................................................................................................................................
Market Access Krankenhaus ............................................................................................................................................................................................................ 37
Patient Support Programme ............................................................................................................................................................................................................ 38
Gesundheitspolitik & Market Access
Erstattung von DiGAs 2021 ............................................................................................................................................................................................................ 39Market Access D-A-CH-Region ............................................................................................................................................................................................................ 39
39
8. Pharma Multichannel Management Tagung ............................................................................................................................................................................................................
40
Statistikwissen und Studieninterpretation ............................................................................................................................................................................................................
Biosimilars 2021 ............................................................................................................................................................................................................ 40
40
Healthcare Management & Market Access-Lehrgang ............................................................................................................................................................................................................
40
Key Account Management im regionalen Market Access ............................................................................................................................................................................................................
41
Nutzenbewertung in der nächsten Legislaturperiode ............................................................................................................................................................................................................
41
Market Access ATMP/Gentherapeutika ............................................................................................................................................................................................................
Medical Writing - Fokus AMNOG ............................................................................................................................................................................................................41
41
Pharma-Key-Account-Management ............................................................................................................................................................................................................
All about ATMP ............................................................................................................................................................................................................ 42
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 42
42
Crashkurs Pharma Business Development ............................................................................................................................................................................................................
Market Access Krankenhaus ............................................................................................................................................................................................................ 42
Marktzugang für Impfstoffe ............................................................................................................................................................................................................ 43
Pharmarecht
44
Effizientes Reklamationsmanagement im GMP-Umfeld ............................................................................................................................................................................................................
44
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
44
Sommerspecial Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
Fortbildungen für Ärzte ............................................................................................................................................................................................................ 44
45
Aktuelle Rechtsprechung und Praxistipps zur Pharma- und Medizinproduktewerbung ...............................................................................................................................................................................
45
Arzneimittel - Medizinprodukte - Lebensmittel - Kosmetika ............................................................................................................................................................................................................
Großhandelsbeauftragte ............................................................................................................................................................................................................ 45
45
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
46
Lizenzierung, Zulassungs- und Produktkauf ............................................................................................................................................................................................................
Betäubungsmittel ............................................................................................................................................................................................................ 46
Rechtssicheres Pre-Marketing ............................................................................................................................................................................................................ 46
46
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 47
47
Crashkurs Pharma Business Development ............................................................................................................................................................................................................
47
Informationsbeauftragter - Sommerakademie ............................................................................................................................................................................................................
Market Access Krankenhaus ............................................................................................................................................................................................................ 47
Tiergesundheit
GDP für Tierarzneimittel ............................................................................................................................................................................................................ 48
Zulassung von Tierarzneimitteln ............................................................................................................................................................................................................48
Medizinprodukte
Erstattung von DiGAs 2021 ............................................................................................................................................................................................................ 49
49
Klinische Prüfung von Medizinprodukten 2021 ............................................................................................................................................................................................................
CDISC ............................................................................................................................................................................................................ 49
50
Stoffliche Medizinprodukte: Neue Herausforderungen durch die Medical Device Regulation (MDR) ..........................................................................................................................................................
50
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
ISO/TR 20416:2020 ............................................................................................................................................................................................................ 50
50
Medical Devices in Russia and the Eurasian Union ............................................................................................................................................................................................................
51
IITs und sonstige klinische Prüfungen mit Medizinprodukten ............................................................................................................................................................................................................
Der Medizinprodukte-Handel ............................................................................................................................................................................................................ 5151
Aktuelle Rechtsprechung und Praxistipps zur Pharma- und Medizinproduktewerbung ...............................................................................................................................................................................
51
Arzneimittel - Medizinprodukte - Lebensmittel - Kosmetika ............................................................................................................................................................................................................
52
Kombinationsprodukte - neue Anforderungen an bestehende und neue Zulassungen ................................................................................................................................................................................
52
Regulatory Compliance und Change Control bei Medizinprodukten ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 52
Kosmetik & Herbals
Basiswissen Kosmetische Mittel ............................................................................................................................................................................................................ 53
53
Phytopharmaka & Homöopathika: Regulatory-Affairs-Essentials ............................................................................................................................................................................................................
53
Arzneimittel - Medizinprodukte - Lebensmittel - Kosmetika ............................................................................................................................................................................................................
Fachseminare für die Assistenz
Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 54
54
GMP-kompakt für das Back Office ............................................................................................................................................................................................................
54
Regulatory Affairs für Assistenzen/Associates ............................................................................................................................................................................................................
54
GMP-Essentials im Qualitätsmanagement ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 55
55
Das 1x1 der Arzneimittelsicherheit ............................................................................................................................................................................................................
Seminare in der Schweiz
56
Successful Medical and Scientific Writing ............................................................................................................................................................................................................
56
Arzneimittel - Medizinprodukte - Lebensmittel - Kosmetika ............................................................................................................................................................................................................
56
Regulatory Affairs für Assistenzen/Associates ............................................................................................................................................................................................................
Seminare in englischer Sprache
57
Improve your Regulatory Intelligence (RI) Skills ............................................................................................................................................................................................................
57
Medical Devices in Russia and the Eurasian Union ............................................................................................................................................................................................................
Toxicology Summer School ............................................................................................................................................................................................................ 57
57
Risk based Pharmacovigilance audits ............................................................................................................................................................................................................
58
Marketing Authorisation in Latin America ............................................................................................................................................................................................................
58
EU Regulatory Affairs introductory training course ............................................................................................................................................................................................................
58
Scientific ENGLISH Writing and Reviewing in Regulatory Affairs ............................................................................................................................................................................................................
Annual CMC Conference ............................................................................................................................................................................................................ 58
Online-Serien & e-Learnings
59
Regulatory Affairs Online-Ausbildung ............................................................................................................................................................................................................
59
e-Learning: Der Medizinprodukteberater im Netz ............................................................................................................................................................................................................
Hot Topics im Futtermittelrecht ............................................................................................................................................................................................................ 59
59
Webcast-Serie Lebensmittel- und NEM-Kennzeichnung ............................................................................................................................................................................................................
60
PharmaFORUM Webcast International ............................................................................................................................................................................................................
Blitzlicht: Update Kosmetikrecht ............................................................................................................................................................................................................60
Online Pharma FORUM ............................................................................................................................................................................................................ 60
60
PharmaFORUM Webcast Akademia ............................................................................................................................................................................................................
60
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