2026-03-21 2026-03-21 , online online, 220 € zzgl. MwSt. Qualification Course Regulatory Affairs Manager

With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.

Themen

EU pharmaceutical law and regulatory framework
Marketing authorisation procedures
Application types and regulatory strategies
Submission planning and dossier management
Post-authorisation activities, including renewals and variations
Optional deep dives into global regulatory regions, such as GCC, EAEU and LATAM

Who should attend

The course is aimed at specialists and managers in the pharmaceutical industry as well as service providers who wish to build, expand or deepen their expertise in regulatory affairs.

Depending on the selected modules, participants may choose EU-focused topics and/or global regulatory areas. This flexibility allows the programme to be tailored to individual professional requirements.

The course is suitable for beginners and career changers who wish to enter the field of drug regulatory affairs, as well as for participants with prior experience. Depending on the chosen modules, the programme can provide an introductory foundation or support advanced professional development in specialised or global regulatory topics.

Ziel der Veranstaltung

This qualification course provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional EU and/or global regulatory affairs online trainings.

All trainings include comprehensive downloadable documentation and a certificate of participation. After completing all required modules, you will receive the FORUM certificate "Qualification Course Regulatory Affairs Manager".

Teilnehmerkreis

Flexible completion within a few weeks or up to 18 months
Structured learning path with modular content selection
Practical understanding of EU marketing authorisation principles
Opportunity to deepen knowledge in European or global regulatory affairs
Up to 30 % savings compared to individual bookings