Regulatory Affairs Starter Pack
Your fast track into EU Regulatory Affairs - self-paced & flexible
- Structured learning path
- Flexible learning units & knowledge checks
- 3 e-learnings, 1 price - save over 30%
- Officially certified according to ISO 9001 and 21001
Module
Regulatory Affairs Starter Pack
Your fast track into EU Regulatory Affairs - self-paced & flexible
Mehr erfahrenThree e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU Regulatory Affairs - at a special bundle price.
Wählen Sie ein Modul zum Thema:
Wahlmodul
Three e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU Regulatory Affairs - at a special bundle price.
Your speakers
Dr. Christian M. Moers
Sträter Lawyers, Bonn, GERMANY
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product…
Your speaker
Dr. Christian M. Moers
Sträter Lawyers, Bonn, GERMANY
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product law
- Marketing authorisation law & regulatory affairs
- Pharmacovigilance
- Wholesale trade with medicinal products, distribution of medicinal products
- Manufacture of medicinal products
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, THE NETHERLANDS
Regulatory Consultant
Your speaker
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, THE NETHERLANDS
Regulatory Consultant
Lidia Cánovas
ASPHALION S.L.,
Barcelona, SPAIN
General Manager, Regulatory Affairs Director;
Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical…
Your speaker
Lidia Cánovas
ASPHALION S.L.,
Barcelona, SPAIN
General Manager, Regulatory Affairs Director;
Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.
Michael Schaub
ASPHALION S.L., Munich, GERMANY
Director Munich Office
Michael has broad experience in European, FDA and RoW registration procedures. He has acquired specialist knowledge in the implementation of…
Your speaker
Michael Schaub
ASPHALION S.L., Munich, GERMANY
Director Munich Office
Michael has broad experience in European, FDA and RoW registration procedures. He has acquired specialist knowledge in the implementation of eSubmission standards, the regulatory support for innovative products such as biologicals, biosimilars and ATMPs, as well as the preparation of paediatric investigation plans. Nowadays, his responsibilities include the strategy and the management of international drug registration procedures, evaluation of the respective dossiers as well as carrying out scientific advice procedures and presubmission meetings with international regulatory authorities.
What to Expect
- e-Learning 1: Introduction to EU Marketing Authorisation: Regulatory affairs principles, procedures, application types and maintenance
- e-Learning 2: EU Variation System & Procedures: Lifecycle management, variation classification, grouping, worksharing & submission
- e-Learning 3: Common Technical Document & eCTD: CTD structure, format and content, validation, CMC data
Who Should Attend
- Professionals and career changers entering the field of Regulatory Affairs with no or limited prior experience.
- Colleagues from adjacent functions (Quality Assurance, Medical Affairs, CMC, Pharmacovigilance, Market Access, Business Development...) who need a working knowledge of EU regulatory procedures.
- Companies onboarding new team members in Regulatory Affairs.
No prior regulatory experience is required.
Objective of the Event
This self-learning course gives you a practical introduction to the three essentials of EU Regulatory Affairs: marketing authorisation procedures, the variation system and the eCTD. Upon completion, you will have a solid understanding of:
- How marketing authorisations are obtained and maintained in the EU
- How to classify, prepare and submit variations
- How regulatory dossiers are structured and submitted
The bundle is designed as a self-contained learning path. You will receive access to our learning platform and can work through all 3 e-Learnings within 90 days.
- Your time investment: 10,5 learning units (1,5 working days) in total.
- Your learning units: Flexible sessions from 10 minutes to half a day - you set the pace.
- Your benefit: A solid foundation in EU Regulatory Affairs - ready to apply from day one.
Your Benefit
- 3 e-Learnings, 1 price - save over 30% compared to individual bookings
- Structured learning path & flexibility - 90 days access, learn at your own pace, anytime, anywhere
- Tests & certificates of completion for each module (*)
(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.
Downloads
Request the documents using our form.
Brochure
List of Abbreviations Pharmacovigilance
Weitere Informationen
How is the course structured?
The self-learning course consists of three e-learning modules covering the following key topics: EU marketing authorisation procedures, the variation system and the Common Technical Document (CTD).
The e-learnings primarily include videos, audio content, texts, interactive exercises, and knowledge checks.
How does it work?
- You book the course on our website.
- You will receive an email with your login details for our customer portal and will be forwarded from there to the learning platform.
- You start your e-learning modules at your own pace and at any time that suits you.
- You complete each module with a short knowledge check.
- After successfully completing each module, you will receive a certificate as proof of completion.
Try the free demo version of our e-learning modules and get a first impression of our learning environment.
Other Options:
You prefer to ask questions directly and connect with other participants? Then we recommend our introductory live online seminars. You can find an overview here:
https://www.forum-institut.com/area/2620-regulatory-affairs-vigilance
Or get in touch with us directly for a personal consultation.
Further Information
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
List of abbreviations pharma & healthcare
Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
Our rating in 2025
More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.
Your Contact Person
We are happy to advise you personally and individually.
Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de