Virtual Classroom Training

Bespoke interactive e-learning

High-level introduction into Regulatory Affairs in the EU (basics only).

Type: Virtual Classroom Training

Duration: 1 Day (divided into two 0.5-day sessions)

Who should attend?: Beginners, career changers, persons with interface to Regulatory Affairs department

High-level introduction into Regulatory Affairs in the EU (basics only)

  • Why medicines need to be regulated
  • Interfaces of Regulatory Affaris department in pharmaceutical industry
  • Pharmaceutical Product Lifecycle
  • Principles for the authorisation process of medicinal products in the EU
  • Structure and content of marketing authorisation dossier
  • Legal base (types of applications in the EU)
  • EU approval processes (i.e. national, CP, MRP, DCP
  • EU post-approval processes (e.g. variations, renewals)

Dr. Jürgen Hönig

Jürgen joined PharmaLex in 2015 as Service Area Head and Head of Regulatory Affairs, where he was responsible for all worldwide submission activities for clinical trial applications, new marketing authorizations, and lifecycle management activities.

In April 2020 changed his responsibilities to analyze local and global trends in regulatory affairs and industry having an impact on the service portfolio of PharmaLex.

Jürgen has more than 20 years of experience within consultancy in Regulatory Affairs and Pharma R&D and about 15 years of experience within Regulatory operations.

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