Veranstaltungsübersicht - Pharma & Healthcare Januar bis März 2022 - FORUM Institut
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Veranstaltungsübersicht Januar bis März 2022 Pharma & Healthcare
Inhaltsverzeichnis
Forschung & Klinische Forschung
Registerstudien ............................................................................................................................................................................................................ 1
1
EU Clinical Trials Regulation: Umsetzung in die Praxis ............................................................................................................................................................................................................
1
IMPD: Anforderungen an CMC-Daten ............................................................................................................................................................................................................
Internationale KliFo-Verträge ............................................................................................................................................................................................................ 1
Toxicology Winter School ............................................................................................................................................................................................................ 2
2
Medizinprodukte-Studien nach CE ............................................................................................................................................................................................................
2
Successful Medical and Scientific Writing ............................................................................................................................................................................................................
2
Kompaktwissen Klinische Prüfung ............................................................................................................................................................................................................
Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 3
3
Statistische Grundlagen klinischer Prüfungen ............................................................................................................................................................................................................
3
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
3
On-site Monitoring klinischer Prüfungen ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 4
4
Publikationen klinischer Arzneimittelprüfungen bewerten ............................................................................................................................................................................................................
Outcomes Research-Lehrgang ............................................................................................................................................................................................................ 4
Remote Audits im GCP-Bereich ............................................................................................................................................................................................................ 4
Digitale NIS ............................................................................................................................................................................................................ 5
GCP für Apotheker ............................................................................................................................................................................................................ 5
5
Multinational Clinical Trials of Medical Devices ............................................................................................................................................................................................................
5
Die Klinische Prüfung nach AMG & ICH GCP ............................................................................................................................................................................................................
All about ATMP ............................................................................................................................................................................................................ 6
6
Patienteninformationen, Einwilligungs- und Datenschutzerklärungen ........................................................................................................................................................................................................
Regulatory Affairs
7
Arzneimittelzulassung für Einsteiger ............................................................................................................................................................................................................
7
Medizinprodukte: Die verantwortliche Person für Regulatory Compliance ..................................................................................................................................................................................................
7
Medical Device Software - MDSW ............................................................................................................................................................................................................
Market Access of Orphan Drugs ............................................................................................................................................................................................................ 8
8
Labelling, UDI & Produktinformationen ............................................................................................................................................................................................................
8
Artwork und Packmittel - Know-how für Praktiker ............................................................................................................................................................................................................
8
IMPD: Anforderungen an CMC-Daten ............................................................................................................................................................................................................
Qualitätsbedingte Variations ............................................................................................................................................................................................................ 9
Regulatory Affairs in the US ............................................................................................................................................................................................................ 9
9
Die Assistenz in der Zulassungsabteilung ............................................................................................................................................................................................................
9
Labelling Management & Artwork ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 10
10
IDMP - what you need to do NOW ............................................................................................................................................................................................................
10
IT-Essentials für Regulatory Affairs ............................................................................................................................................................................................................
10
Grundlagen für Regulatory Affairs von Medizinprodukten ............................................................................................................................................................................................................
11
CMC-Daten für pflanzliche Arzneimittel ............................................................................................................................................................................................................
11
Regulatory Compliance und Change Control bei Medizinprodukten ............................................................................................................................................................................................................
11
Multinational Clinical Trials of Medical Devices ............................................................................................................................................................................................................
11
Regulatory Affairs China and ASEAN CTD ............................................................................................................................................................................................................
All about ATMP ............................................................................................................................................................................................................ 12
12
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
12
Internationale Medizinprodukte-Zulassung ............................................................................................................................................................................................................Pharmakovigilanz
GVP-Auditor ............................................................................................................................................................................................................ 13
Pharmakovigilanz Update 2022 ............................................................................................................................................................................................................ 13
13
Effektives Projektmanagement in der Pharmakovigilanz ............................................................................................................................................................................................................
13
Medizinprodukte: Die verantwortliche Person für Regulatory Compliance ..................................................................................................................................................................................................
Vigilanz für Medizinprodukte ............................................................................................................................................................................................................ 14
Medical Manager ............................................................................................................................................................................................................ 14
14
ICSR Reporting 2022 - your next to dos & challenges ............................................................................................................................................................................................................
14
Das 1x1 der Arzneimittelsicherheit ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 15
15
The Pharmacovigilance System Master File (PSMF) in a Global Environment ..............................................................................................................................................................................................
15
PV audits & inspection strategies - Day 1: Risk based PV audits ............................................................................................................................................................................................................
15
PV audits & inspection strategies - Day 2: Pharmacovigilance Inspection Readiness ...................................................................................................................................................................................
16
Risk Management Plan & Risk Minimisation Measures ............................................................................................................................................................................................................
16
Aufbauwissen für QPPV und Stufenplanbeauftragte ............................................................................................................................................................................................................
16
CAPA Management in der Pharmakovigilanz ............................................................................................................................................................................................................
16
The Person Responsible for Regulatory Compliance ............................................................................................................................................................................................................
17
RMP and PSUR in life-cycle management: An art, not a miracle ............................................................................................................................................................................................................
17
Pharmakovigilanz für Tierarzneimittel - die neue Tierarzneimittelgesetzgebung .........................................................................................................................................................................................
Medical Affairs
18
Winterspecial: Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
Pharma-Marketing-Diplom ............................................................................................................................................................................................................ 18
18
Healthcare Management & Market Access-Lehrgang ............................................................................................................................................................................................................
18
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
19
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
Medical Manager ............................................................................................................................................................................................................ 19
19
Informationsbeauftragter - Winterakademie ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 19
20
Healthcare Storytelling - Geschichten erzählen im New Normal ............................................................................................................................................................................................................
Outcomes Research-Lehrgang ............................................................................................................................................................................................................ 20
20
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
20
Erfolgreiches Projektmanagement in Medical Affairs ............................................................................................................................................................................................................
20
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
Q,SProduktion & Logistik
GVP-Auditor ............................................................................................................................................................................................................ 21
21
Medizinprodukte: Die verantwortliche Person für Regulatory Compliance ..................................................................................................................................................................................................
21
Vom GMP-/GDP-Auditor zum Lead-Auditor ............................................................................................................................................................................................................
Betäubungsmittel-Workshop ............................................................................................................................................................................................................ 22
22
Labelling, UDI & Produktinformationen ............................................................................................................................................................................................................
22
Artwork und Packmittel - Know-how für Praktiker ............................................................................................................................................................................................................
Vigilanz für Medizinprodukte ............................................................................................................................................................................................................ 22
23
MASTER CLASS Großhandelsbeauftragter ............................................................................................................................................................................................................
23
IMPD: Anforderungen an CMC-Daten ............................................................................................................................................................................................................
Standortbestimmung Cannabis ............................................................................................................................................................................................................ 23
Qualitätsbedingte Variations ............................................................................................................................................................................................................ 23Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 24
Der Leiter der Herstellung ............................................................................................................................................................................................................ 24
24
GMP-Essentials im Qualitätsmanagement ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 24
25
Qualitätsrisikomanagement im GDP-Umfeld ............................................................................................................................................................................................................
Betäubungsmittel ............................................................................................................................................................................................................ 25
25
Audits GxP-relevanter computergestützter Systeme: Von lokal bis zur Cloud ..............................................................................................................................................................................................
25
CMC-Daten für pflanzliche Arzneimittel ............................................................................................................................................................................................................
GMP-Verträge 2022 ............................................................................................................................................................................................................ 26
26
Regulatory Compliance und Change Control bei Medizinprodukten ............................................................................................................................................................................................................
Die Sachkundige Person ............................................................................................................................................................................................................ 26
26
Compliance in der Lohnherstellung ............................................................................................................................................................................................................
Werbung, Marketing & Vertrieb
27
Winterspecial: Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
Pharma-Marketing-Diplom ............................................................................................................................................................................................................ 27
Key Account Krankenhaus ............................................................................................................................................................................................................ 27
27
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
28
Kompaktwissen Nahrungsergänzungsmittel ............................................................................................................................................................................................................
28
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
28
Regionale Arzneimittel-Verordnungssteuerung ............................................................................................................................................................................................................
Standortbestimmung Cannabis ............................................................................................................................................................................................................ 28
Medical Manager ............................................................................................................................................................................................................ 29
29
Key Account Management im regionalen Market Access ............................................................................................................................................................................................................
29
Informationsbeauftragter - Winterakademie ............................................................................................................................................................................................................
29
Key Account Management Biosimilars ............................................................................................................................................................................................................
30
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 30
30
Healthcare Storytelling - Geschichten erzählen im New Normal ............................................................................................................................................................................................................
30
Online-Vertrieb von OTC-Arzneimitteln ............................................................................................................................................................................................................
31
Generic Market Access & Pricing in Europe ............................................................................................................................................................................................................
31
KI und Big Data in der Pharmaindustrie - darauf müssen Sie achten ...........................................................................................................................................................................................................
31
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
31
Digitale Strategie für die externe Online-Kommunikation ............................................................................................................................................................................................................
31
Erfolgreiches Projektmanagement in Medical Affairs ............................................................................................................................................................................................................
32
Marketing & Vertrieb von Lifestyle-Arzneimitteln ............................................................................................................................................................................................................
32
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
32
Einkaufsgemeinschaften Krankenhaus ............................................................................................................................................................................................................
Gesundheitspolitik & Market Access
33
Healthcare Management & Market Access-Lehrgang ............................................................................................................................................................................................................
33
Medical Device Software - MDSW ............................................................................................................................................................................................................
Market Access of Orphan Drugs ............................................................................................................................................................................................................ 33
Key Account Krankenhaus ............................................................................................................................................................................................................ 34
34
Nutzenbewertung 2022 - Start von EU-HTA ............................................................................................................................................................................................................
34
Regionale Arzneimittel-Verordnungssteuerung ............................................................................................................................................................................................................
Update Arzneimittel-Festbeträge ............................................................................................................................................................................................................34
35
Key Account Management im regionalen Market Access ............................................................................................................................................................................................................
35
Key Account Management Biosimilars ............................................................................................................................................................................................................Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 35
35
Fachwissen Market Access Onkologie ............................................................................................................................................................................................................
36
Generic Market Access & Pricing in Europe ............................................................................................................................................................................................................
Expanded Access Programmes ............................................................................................................................................................................................................ 36
Outcomes Research-Lehrgang ............................................................................................................................................................................................................ 36
All about ATMP ............................................................................................................................................................................................................ 36
37
Einkaufsgemeinschaften Krankenhaus ............................................................................................................................................................................................................
Pharmarecht
38
Winterspecial: Heilmittelwerberecht und Wettbewerbsrecht ............................................................................................................................................................................................................
38
Digitale Vermarktung: Wettbewerbsrechtliche Grenzen nach HWG und UWG ............................................................................................................................................................................................
38
Kompaktwissen Nahrungsergänzungsmittel ............................................................................................................................................................................................................
38
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
Internationale KliFo-Verträge ............................................................................................................................................................................................................ 39
39
Medizinprodukte-Studien nach CE ............................................................................................................................................................................................................
39
Informationsbeauftragter - Winterakademie ............................................................................................................................................................................................................
39
Datenschutz in der klinischen Forschung ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 40
Betäubungsmittel ............................................................................................................................................................................................................ 40
40
KI und Big Data in der Pharmaindustrie - darauf müssen Sie achten ...........................................................................................................................................................................................................
GMP-Verträge 2022 ............................................................................................................................................................................................................ 40
41
Sponsoring, Advisory Boards & Co. - Healthcare Compliance für Kooperationen mit Ärzten .......................................................................................................................................................................
41
The Person Responsible for Regulatory Compliance ............................................................................................................................................................................................................
41
Patienteninformationen, Einwilligungs- und Datenschutzerklärungen ........................................................................................................................................................................................................
41
Informationsbeauftragte 2.0: Arzneimittelwerbung im Internet ............................................................................................................................................................................................................
42
Einkaufsgemeinschaften Krankenhaus ............................................................................................................................................................................................................
Kosmetische Mittel
Rechtssichere Kosmetikwerbung ............................................................................................................................................................................................................43
43
Healthcare Storytelling - Geschichten erzählen im New Normal ............................................................................................................................................................................................................
Kosmetikrecht CH & EU ............................................................................................................................................................................................................ 43
43
Marketing & Vertrieb von Lifestyle-Arzneimitteln ............................................................................................................................................................................................................
Lebensmittel, NEM & Herbals
44
Praxiswissen Nahrungsergänzungsmittel ............................................................................................................................................................................................................
44
Kompaktwissen Nahrungsergänzungsmittel ............................................................................................................................................................................................................
44
CMC-Daten für pflanzliche Arzneimittel ............................................................................................................................................................................................................
Tiergesundheit
45
Pharmakovigilanz für Tierarzneimittel - die neue Tierarzneimittelgesetzgebung .........................................................................................................................................................................................
Krankenhaus
Key Account Krankenhaus ............................................................................................................................................................................................................ 46
46
Einkaufsgemeinschaften Krankenhaus ............................................................................................................................................................................................................Medizinprodukte
47
Medizinprodukte: Die verantwortliche Person für Regulatory Compliance ..................................................................................................................................................................................................
47
Medical Device Software - MDSW ............................................................................................................................................................................................................
47
Labelling, UDI & Produktinformationen ............................................................................................................................................................................................................
Vigilanz für Medizinprodukte ............................................................................................................................................................................................................ 47
48
Grenzen der Medizinprodukte-Werbung ............................................................................................................................................................................................................
48
Medizinprodukte-Studien nach CE ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 48
48
Healthcare Storytelling - Geschichten erzählen im New Normal ............................................................................................................................................................................................................
49
Grundlagen für Regulatory Affairs von Medizinprodukten ............................................................................................................................................................................................................
49
Regulatory Compliance und Change Control bei Medizinprodukten ............................................................................................................................................................................................................
49
Multinational Clinical Trials of Medical Devices ............................................................................................................................................................................................................
49
The Person Responsible for Regulatory Compliance ............................................................................................................................................................................................................
50
Internationale Medizinprodukte-Zulassung ............................................................................................................................................................................................................
Seminare: Schweiz & Österreich
Pharmakovigilanz Update 2022 ............................................................................................................................................................................................................ 51
51
Praxiswissen Nahrungsergänzungsmittel ............................................................................................................................................................................................................
51
Successful Medical and Scientific Writing ............................................................................................................................................................................................................
Kosmetikrecht CH & EU ............................................................................................................................................................................................................ 51
Fachseminare für die Assistenz
Biotechnologie für Einsteiger ............................................................................................................................................................................................................ 52
52
Die Assistenz in der Zulassungsabteilung ............................................................................................................................................................................................................
52
GMP-Essentials im Qualitätsmanagement ............................................................................................................................................................................................................
52
Das 1x1 der Arzneimittelsicherheit ............................................................................................................................................................................................................
Medizinprodukte für Einsteiger ............................................................................................................................................................................................................ 53
Seminare in englischer Sprache
Market Access of Orphan Drugs ............................................................................................................................................................................................................ 54
Toxicology Winter School ............................................................................................................................................................................................................ 54
54
The EU Qualified Person for Pharmacovigilance (EU-QPPV) ............................................................................................................................................................................................................
Regulatory Affairs in the US ............................................................................................................................................................................................................ 55
55
IDMP - what you need to do NOW ............................................................................................................................................................................................................
55
The Pharmacovigilance System Master File (PSMF) in a Global Environment ..............................................................................................................................................................................................
55
PV audits & inspection strategies - Day 1: Risk based PV audits ............................................................................................................................................................................................................
56
PV audits & inspection strategies - Day 2: Pharmacovigilance Inspection Readiness ...................................................................................................................................................................................
56
Generic Market Access & Pricing in Europe ............................................................................................................................................................................................................
Expanded Access Programmes ............................................................................................................................................................................................................ 56
56
Multinational Clinical Trials of Medical Devices ............................................................................................................................................................................................................
57
Regulatory Affairs China and ASEAN CTD ............................................................................................................................................................................................................
57
The Person Responsible for Regulatory Compliance ............................................................................................................................................................................................................
57
RMP and PSUR in life-cycle management: An art, not a miracle ............................................................................................................................................................................................................Online-Serien & e-Learnings
58
Vendor Management und Oversight in klinischen Prüfungen ............................................................................................................................................................................................................
58
CMC requirements in Asia, Japan and Eastern Europe ............................................................................................................................................................................................................
58
Market Access & Pricing in Europe ............................................................................................................................................................................................................
59
Regulatory Affairs Online-Ausbildung ............................................................................................................................................................................................................
59
PharmaFORUM Webcast International ............................................................................................................................................................................................................
59
PharmaFORUM Webcast Akademia "Quality by Design - auch in IITs" ........................................................................................................................................................................................................
Blitzlicht: Update Kosmetikrecht ............................................................................................................................................................................................................59
59
PharmaFORUM Webcast Clinical Trials "Patient information and Informed Consent Form" ........................................................................................................................................................................
Online Pharma FORUM ............................................................................................................................................................................................................ 60
60
PharmaFORUM Webcast Akademia ............................................................................................................................................................................................................
Online Medizinprodukte FORUM ............................................................................................................................................................................................................60
60
PharmaFORUM Webcast Biologics ............................................................................................................................................................................................................
60
PharmaFORUM Webcast Clinical Trials ............................................................................................................................................................................................................
61
e-Learning: Introduction to EU Marketing Authorisation ............................................................................................................................................................................................................
e-Learning: Basiswissen GMP ............................................................................................................................................................................................................ 61
61
e-Learning: Pharmarecht kompakt ............................................................................................................................................................................................................
61
e-Learning: Patient Engagement in Europe ............................................................................................................................................................................................................
61
e-Learning: Das HWG - Ihr Basiswissen für mehr Rechtssicherheit in der Heilmittelwerbung ......................................................................................................................................................................
62
e-Learning: Medizinprodukte Basics ............................................................................................................................................................................................................
62
e-Learning: Basiswissen GDP für Einsteiger ............................................................................................................................................................................................................
62
e-Learning: Basiswissen Pharmakovigilanz ............................................................................................................................................................................................................
62
e-Learning: Grundzüge des deutschen Gesundheitssystems ............................................................................................................................................................................................................Sie können auch lesen
