Qualification course: Global Regulatory Affairs Manager

You determine the main topics of the training course yourself. Possible focal points are:

• Approval procedures in the EU: Lifecycle management, variations, labelling
• Marketing Authorisation outside the EU: ASEAN, APAC , China, Latin America, Eastern Europe, the USA
• Global CMC: Latin America, Eastern Europe, Japan, MENA, Asia, Eastern Europe, the USA
• Biologics: CMC, regulatory affairs and more

Would you like to have sound know-how in global regulatory affairs, remain flexible in terms of time and set your own professional priorities? Then this is the right place for you.

The concept: As a mandatory module you register for one year membership for our PharmaFORUM Webcast International. International regulatory affairs experts will inform you about the latest news and trends in global marketing authorisation in a 1.5 to 2 hour live webcast every two months (six webcasts in total). Moreover, you select four further seminar modules (= 4 seminar days or webcast series) that support your professional development, region- or country-specific. In this way, you qualify as a "Global Regulatory Affairs Manager" in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute. Achieve your further training goal efficiently and precisely with us.

This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in global regulatory affairs.