Variations in Europe
Your regulatory and procedural guidance
- Classification and submission
- Type IA notification, Type IB and II variations
- Grouping and worksharing
- Variation management
- Quality-related variations: Changes in the production process, analytics, formulation and packaging
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.
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)
- Variation Regulation, Classification guideline
- Changes according to the Variation Regulation vs purely national changes
- Type IA-changes according to the classification guideline
- Annual report
- Immediate notification (Type IAIN)
10:30 Coffee break
- Type IB-changes according to the classification guideline
- Timelines and processing
- Type IB by default
- Processing of type II variations
- Timelines, 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 MA 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 deadlines
17:00 Day 1 ends
- Notification or variation
- Batch size change
- Change in the manufacturing flow
- Tech transfer/site transfer?
10:30 Coffee break
- API and excipient new suppliers
- How to assess a change and build a submission plan
- Changes of: Contract laboratories Analytical methods Acceptance criteria Specifications Regulatory change management
14:30 Coffee break
- Primary/secondary packaging (specification, testing)
- Change of packaging sites
- Labelling impact
17:00 Seminar ends
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).
General Manager; 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.
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 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.
Scientific & Regulatory Affairs Director; André has more than 14 years' experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different countries, with several types of products, and for different types of companies. Besides his core CMC expertise, he is mainly focused on CMC writing and strategic guidance, he has also been deeply involved in other relevant areas, such as: - Project lead/management of global projects, - Implementation of EMA Policy 0070 (clinical data transparency), and - eCTD publishing.
Nähere Informationen finden Sie hier.
2 April 2020Donnerstag, 02.04. - 09:00 bis 17:30 Uhr
Kora Doorduyn-van der Stoep
3 April 2020Freitag, 03.04. - 09:00 bis 17:00 Uhr
Dr Veronika Alt, Cristina Elena Stanca
NL 2332 KG Amsterdam / Leiden
Phone: +31(0) 71 535 5555
Fax: +31(0) 71 53 55 553
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).
Small group, possible to adress many questions, practical examples.
Exchange of experience.
Good general overview.
To learn from other experiences. To have one person from authority as expert.
Good organisation and interesting topics in a nice atmosphere.