Qualification Course Regulatory Affairs Manager
- You gain a comprehensive foundation in RA.
- You strengthen your professional qualifications.
- You choose individual focus areas.
- You save up to 30% compared with individual bookings.
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.
Your speaker
What to Expect
- EU and global 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
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.
Objective of the Event
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".
Your Benefit
- Flexible completion within a few weeks or up to 18 months
- Structured learning path with modular content selection
- Practical understanding of marketing authorisation principles
- Opportunity to deepen knowledge in European or global regulatory affairs
- Up to 30 % savings compared to individual bookings
Downloads
Request the documents using our form.
Weitere Informationen
How is the qualification course structured?
The qualification course consists of one mandatory e-learning module and at least two elective live online seminar modules.
1. Mandatory e-learning (self-study): "Introduction to EU Marketing Authorisation"
Aim: Build a solid foundation in regulatory affairs for medicinal products within the European Union.
2. Elective modules (live online seminars): individual focus areas
Aim: Deepen your expertise in the areas most relevant to your professional practice.
To receive your certificate, you are required to complete the mandatory e-learning module, which comprises 2.5 teaching units, and at least 13 additional teaching units from a minimum of two different elective live online seminar modules. This results in a minimum total of 15.5 teaching units.
The overall duration depends on the modules you choose and amounts to at least two working days. Exact timings are provided in the respective module descriptions. You have up to 18 months to complete the programme, but you may also finish it within just a few weeks.
After registering, you will receive your confirmation and access details for your customer portal, where you will find all relevant information and documents and can begin your online learning.
How does the pricing work?
The minimum total course fee for the qualification course is EUR 2,000 (plus VAT).
The qualification course includes the following cost elements:
Mandatory e-learning module: The e-learning course "Introduction to EU Marketing Authorisation" comprises 2.5 teaching units and is charged at EUR 180 plus VAT.
Elective modules: To receive your certificate, you are required to complete at least 13 additional teaching units from a minimum of two different elective live online seminar modules. Elective modules are charged at EUR 140 per teaching unit plus VAT. If you wish, you may book further elective modules beyond the minimum certificate requirements at the same rate.
Payment is due within 21 days of receipt of the final invoice. Our General Terms and Conditions, as amended, shall apply. They are available at cancellation policy or can be provided to you upon request.
Your plans change during the programme?
No problem. Up to 14 days before the respective seminar module, you may reschedule to a different date or switch to another seminar, subject to a processing fee of €50 plus statutory VAT.
How do I book?
When booking the qualification course online, you select your elective modules directly during the booking process. Our portfolio of EU and / or global regulatory affairs trainings is continuously expanding. New seminars are added regularly, giving you additional options for your qualification course.
Our team will be happy to support you in choosing the right combination.
Verena Planitz – Global regulatory affairs
v.planitz@forum-institut.de
+49 6221 500-655
Jean-Marie Bayhurst – EU regulatory affairs
j.bayhurst@forum-institut.de
+49 6221 500-685
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de