EU Regulatory Affairs Introductory Training Course
Marketing authorisation in Europe for beginners
- Day 1: Marketing Authorisation Procedures in Europe Legal basis, Mutual recognition, decentralised and centralised procedure in detail
- Day 2: Marketing Authorisation Documents Data for the dossier, key elements and structure of the SmPC and the package leaflet
- Day 3: Regulatory Life Cycle Management Variations, Renewals, eCTD and electronic submission
This distinguishes our event
EU Regulatory Affairs Introduction CourseThis introductory training course will inform you about all the important obligations and challenges in regulatory affairs. You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory life cycle management for a product and the structure and submission of an electronic dossier.
- The regulatory framework: regulations, directives and guidelines
- Involved authorities
- The available marketing authorisation procedures: centralised, decentralised and national
- Full application, bibliographic application, mixed application and informed consent
- Generic application, hybrid application and biosimilars
11:00 Coffee break
- Common principles
- Submission strategy
- Deadlines and clock stops
- Scope and mandatory products
- Roles of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) and national authorities
- The procedure in detail
15:00 Coffee break
- Data exclusivity and innovation protection
- European reference product
17:00 End of Day 1
- Cover letter, application form, etc.
- National peculiarities
- Core documents and data
- Common errors and authority findings
- Practical exercises
- Compilation of preclinical and clinical data
- How to present study reports
- Common errors and authority findings
- Common principles for overviews and summaries
- Practical examples
15:00 Coffee break
- Key elements and structure of the SmPC and the package leaflet
- QRD templates
- Educational material
17:00 End of Day 2
09:00 Beginning of Day 3
- Variations, renewals, pharmacovigilance and further responsibilities
10:30 Coffee break
- Type IA/B notifications and Type II variations - correct classification
- How to complete the application form
- Grouping and worksharing
- Classification with the help of practical examples
- eCTD basic principles: Structure, document requirements and lifecycle management
- EU Module 1 requirements
15:30 Coffee break
- Submission to the authorities: electronic application forms and portals (CESSP and EMA Gateway)
- Other eSubmission projects: xEVMPD, SPOR and ISO IDMP
17:00 End of seminar
Vice-Chairperson CMDh NL-CMDh member/Senior Policy Adviser Kora Doorduyn works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures - Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).
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
Nähere Informationen finden Sie hier.
Associate Director; Remco has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission and regulatory data management. He has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Key areas of expertise include: - Regulatory submissions (new MAA to variations) - Global eCTD submission - Regulatory Information Management systems (RIM) - xEVMPD - ISO IDMP
Regulatory Affairs Professional; Cristina Elena Stanca is an independent consultant with 7 years regulatory experience in the Pharma (human/veterinary use products) and Medical Devices industries, covering the EU and rest of the world, from sterile products to oral solid dosage forms. As a member of TOPRA and the Royal Society of Chemistry she engaged with professionals worldwide and built good relationships with various agencies and independent consultants. With regard to product life-cycle management, she has a good knowledge and understanding of EU regulations and associated guidelines for MRP/DCP/CP/national applications. Cristina has a BSc. in Chemistry and MSc. in Environmental Protection and has worked for Nestlé, B.Braun, Mylan and MSD, being responsible for products from a wide range of therapeutic areas.
Director Global Regulatory Policy
25 November 2019Montag, 25.11. - 09:00 bis 17:00 Uhr
Kora Doorduyn-van der Stoep, Dr Christian M Moers, TBA
26 November 2019Dienstag, 26.11. - 09:00 bis 17:00 Uhr
TBA, Aimad Torqui
27 November 2019Mittwoch, 27.11. - 09:00 bis 17:00 Uhr
TBA, Remco Munnik
NL 1011 Amsterdam
Phone: +31 20 5300800
Fax: +31 20 5300801
- Knowledge of the regulatory affairs procedures in Europe.
- Knowledge of the requirements and deadlines for each procedure.
- The ability to choose the most suitable procedure for your product.
- The ability to contribute to the submission process.
- Proficiency in compiling the necessary documents.
- Knowledge of the structure and content of the SmPC and the package leaflet.
- Understanding of the principles of electronic submission.
- Knowledge of the requirements for regulatory life cycle management.
This seminar is a blended learning programme of the FORUM Institute and creates the necessary prerequisites for an optimal knowledge transfer into daily practice. Participants of all three seminar days will receive access to our e-learning "Introduction to EU Marketing Authorisation" two weeks before the seminar. It will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe in five modules.
You have the option to organise your training according to your level of expertise and requirements. Each day can either be booked separately or in combination with another day. Simply choose the topics you need. Participants of all three seminar days will receive access to our e-learning "Introduction to EU Marketing Authorisation" two weeks before the seminar for an optimal preparation to this training course.
It has been a way to get the principals regarding the EU regulatory affairs and useful links, database, material.
Discussions, a benefit, improvement
Current, relevant information, comprehensive.
To get the input from persons who work(ed) in agencies. To be more aware of the common mistakes done when submitting applications for MA.
The event was well structured and organised. The topics werre interesting as well as most of the presentations. Good quality study material was provided.
Broad overview provided.
Structure, great experience of the speakers.
The entire programm in detail.
Very good overview of EU Regulatory Affairs.
Biofrontera Bioscience GmbH
A good and complete course.