Regulatory Affairs for other Disciplines - 5 lectures in total 5 h (10316)

The webinar is designed for colleagues from other departments outside of regulatory affairs in pharmaceutical companies, API manufacturers and service providers. It is intended to provide an overview of the requirements for marketing authorisation and the corresponding changes in Europe, whereby differences to the US system are also explained. With the contents conveyed, the specialist departments working on marketing authorisation (with a focus on the Q departments) should be in a better position to anticipate specific marketing authorisation requirements and to take these into account when preparing marketing authorisation-relevant documents.

The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Part 1 | Marketing Authorisations for Pharmaceuticals - legal requirements (EU/US) 
Duration about 85 minutes

• Relevant authorities in Europe
• Relevant authorities USA
• European requirements / EMA and EU Commission
• US requirements /FDA
• International harmonisation / ICH
• Role of pharmacopoeias (EP/USP)

Part 2  | National authorisation procedures, EU and international authorisation procedures
Duration about 100 minutes

• Types of approval EU
  • Full Application
  • Generic Application
  • Hybrid Application
  • Well-established use
  • Traditional registration
• Types of registration USA
  • NDA
  • ANDA
  • BLA
• National registration in Europe
• Decentralised procedures (DCP/MRP)
• Centralised approval in the EU
• Approval procedure in the USA
• Special procedures
• International recognition of marketing authorisation decisions

Part 3 | Marketing authorisation application including marketing authorisation dossier, structure and contents of the CTD/eCTD
Duration about 60 minutes

• Modules 1, 4 and 5
• Module 2 and 3 - CMC data
• Module 2.3 in USA

Part 4 | API dossiers (e.g. ASMF, CEP, DMF)
Duration about 45 minutes

• Active substance dossiers in Europe (CEP/ASMF)
• Active substance dossier in the USA

Part 5 | Variation requirements for the finished medicinal product
Duration about 60 minutes

• Life cycle concepts for marketing authorisations
• ICH Q12
• Variations Regulation in Europe
  • Classification of changes (Type IA and IB Notifications, Type II Variations, Line extension)
  • Procedure for variation application depending on the procedures (national, decentralised, centralised)
• Changes in USA

Duration of the recording: approx. 325 minutes in total
Lecture language: English | Slides: English

...your speaker Dr. Markus Veit...

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Note on quota call-off: When booking the entire webinar series, five units per participant will be deducted.

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