Variations in Europe
Your regulatory and procedural guidance
- Day 1: Classification and submission
- Fundamentals and classification
- Type IA notification
- Type IB and II variations
- Grouping and worksharing
- Variation submission Day 2: Quality-related variations
- Changes in the production process
- Changes in the formulation and analytics
- Package and production variations
Aims and objectivesThis seminar will bring you the latest in the planning, classification and submission of variations.
Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation (e-)application form and organisation of grouping and work sharing.
Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the classification guideline and the Q&A paper will reinforce your knowledge.
involved in planning, creating or submitting
Employees in the following departments will
particularly benefit from the seminar:
- regulatory affairs;
- production; and
- quality assurance
Day 2: 09:00-17:00 seminar
(08:30 registration on both days)
- Basics of the European Variations system
- Variation Regulation
- Variation vs. Notification
- Classification guideline
- Changes according to the Variation Regulation versus purely national changes
10:30 Coffee break
- Type IB-changes according to the classification guideline
- Processing of type B variations
- Type IB by default
- Processing of type II variations
- Submission and Validation
- Grouping of type IA Notifications
- Grouping of extensions and other variations
- Grouping of different types of variations
- Practical examples
- Efficient Variation management
- E-only, consequences for the marketing authorisation dossier
- Variation (e)-Application Form
- CEP Submission
- Technical requirements
15:15 Coffee break
- Safety related changes and urgent safety restrictions
- Line Extensions; "Unforeseen" Variations
- Strategic planning and deadline management
17:00 End of day 1
- Notification or Variation
- Batch size change
- Change in the manufacturing flow
- Tech transfer/site transfer?
10:30 Coffee break
- Additives and fillers/API
- New suppliers
- Changes of:
- Contract Laboratories
- Analytical methods
- Acceptance criteria
- Regulatory Change management
14:30 Coffee break
- Primary packaging
- Changes at the production site
- Practical work with the classification guideline and with the Q&A paper (CMDh)
17:00 End of the seminar
Governance, Regulatory and International affairs Department
Junior Consultant Regulatory Affairs
Consultant Regulatory Affairs Michiel has been working in the industry since 2005, starting off in marketing but very soon moving forward to Regulatory Affairs. He has a MSc degree from the University of Wageningen in animal biology and has extensive experience in managing marketing authorisations after working for several generic and innovator pharmaceutical companies.
Nähere Informationen finden Sie hier.
Rabiea Abdullah is a former Quality Assessor in the EU Regulatory Agency, the MHRA. In this role she was responsible for assessing the quality (CMC) component of the dossier with respect to EU variation and marketing authorisation applications. Following on from this she has worked with MSD as a product lead for various products supporting quality variation submissions to the EU and other regions.
Senior Consultant Regulatory Affairs, Head of eCTD Senior Consultant Regulatory Affairs and Head of ERA's eCTD group with over 10 years' experience in regulatory affairs. Veronika works on the life-cycle management of several MAAs and successfully completed many post-marketing variations for biological medicinal products. She has a scientific background with a doctoral degree in technical chemistry (biotechnology) and many years of experience in purification and analytical method development and validation of various components, including peptides and proteins.
Regulatory Affairs Specialist CMC - EU/EEMEA Region
8 April 2019Montag, 08.04. - 09:00 bis 17:30 Uhr
Kora Doorduyn-van der Stoep, Michiel Hendriks, Marta Gorecka
9 April 2019Dienstag, 09.04. - 09:00 bis 17:00 Uhr
Rabiea Abdullah, Dr Veronika Alt, Cristina Elena Stanca
NL 1054 Amsterdam
Phone: +31 20 6075555
Fax: +31 20 60075511
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 the other day. Simply choose the topics you need. If you are new to regulatory affairs, we also recommend our "Introduction to EU Marketing Authorisation" e-learning programme.
Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation' e-learning programme.
This programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.
The e-learning programme 'Introduction to EU Marketing Authorisation' comprises five didactic modules that include videos in which the expert Dr Christian Moers shares his expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the five modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Please register for the seminar "Variations in Europe" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €290 + local VAT rather than €390 + local VAT).