E-learning
#Affari Regolatori / Farmacovigilanza , #Marketing

Common Technical Document & eCTD

including CMC requirements for marketing authorisation applications
dal 01/01/2023 al 31/12/2023
Online
On demand
Lidia Cánovas, ASPHALION S.L., Barcelona, SPAIN

Michael Schaub, ASPHALION S.L., Munich, GERMANY
- CTD principles and structure
- Format and content of Module 1 - 5 CTD
- CMC data required for Module 3 (drug substance and drug product)
- Dossier requirements for generics and further abridged procedures
- Dossier requirements for ASMF and CEP submissions
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#Affari Regolatori / Farmacovigilanza , #Marketing

Introduction to EU Marketing Authorisation

Principles, Procedures, Application Types and Maintenance
dal 01/01/2023 al 31/12/2023
Online
On demand
Dr. Christian M. Moers, Sträter Lawyers, Bonn, Germany
- Module 1: Overview of the law and EU regulatory network
- Module 2: Principles (The European Economic Area & the scope of Directive 2001/83/EC)
- Module 3: Procedures (MRP, DCP, CP, Referrals)
- Module 4: Application types (legal basis, CTD requirements, Generics, Herbals)
- Module 5: Post authorisation (Renewals, Sunset Clause, Variations)


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#Affari Regolatori / Farmacovigilanza , #Affari Regolatori / Farmacovigilanza

EU Variation System & Procedures

Classification, Grouping, Worksharing & Submission
dal 01/01/2023 al 31/12/2023
Online
On demand
Ingrid Prieschl, Zwiers Regulatory Consultancy B.V.
- Module 1: Overview of the EU law and Guidelines
- Module 2: Classification of Variations
- Module 3: Procedural Aspects of Variations
- Module 4: Grouping and Worksharing
- Module 5: Application Form et cetera
- Module 6: Other Post-Authorisation Procedures
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#Ricerca Clinica (R&D, Sperimentazione, Medical Affairs) , #Ricerca Clinica (R&D, Sperimentazione, Medical Affairs)

Stability Testing in the ICH Region

Stability testing for chemical and biological products in the ICH region
dal 01/01/2023 al 31/12/2023
Online
On demand
Dr. Beatrix Metzner, Boehringer Ingelheim Biopharmaceuticals GmbH, Biberach an der Riss
- Module 1: Regulatory requirements
- Module 2: Factors that influence stability testing
- Module 3: Stability test requirements
- Module 4: Bracketing and matrixing
- Module 5: Shelf life and extrapolation - Challenges
- Module 6: Impact of changes on stability
- Module 7: Challenges for biotechnological products
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#Affari Regolatori / Farmacovigilanza , #Ricerca Clinica (R&D, Sperimentazione, Medical Affairs)

CTD Module 3

Data requirements in the EU
dal 01/01/2023 al 31/12/2023
Online
On demand
Lidia Cánovas, ASPHALION S.L., Barcelona, SPAIN
- CTD structure and applicable guidelines
- Drug substance Part
- ASMF and CEP
- Drug product part


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#Marketing , #Market Access/Patient Access

Market Access for Medical Devices - The NUB Process

Master the NUB process in the German healthcare system
dal 01/01/2023 al 31/12/2023
Online
On demand
Sven Sauermann, Managing Director, Market Access and Reimbursement Consultant
- Module 1: Introduction to Market Access and Reimbursement
- Module 2: The German Healthcare System
- Module 3: Access pathways - NUB
- Module 3.1: The NUB proposals - form of application
- Module 3.2: Scenarios - Examples from submitted NUB proposals
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#Market Access/Patient Access

Patient Engagement in Europe

Compliance - Collaboration - Measurement
dal 01/01/2023 al 31/12/2023
Online
On demand
Dr. Andreas L.G. Reimann, MBA, admedicum Business for Patients GmbH & Co KG, Cologne

Philipp von Gallwitz, admedicum Business for Patients GmbH & Co KG, Cologne
- Module 1: Why Patient Engagement
- Module 2: Patient Landscape
- Module 3: Legal and Behavioural Compliance
- Module 4: Contacting Patients and Patient Organisations
- Module 5: Collaboration and Co-Creation
- Module 6: Performance Measurement
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