Presented by
Management Forum
EU (European Union) Proposed Pharmaceutical Legislation Changes In-house Training
A Regulatory Update
This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
Course overview
It is essential that companies are aware of proposed changes to pharmaceutical legislation in the EU and the potential impact on company planning and strategy.
The UK is no longer a member of the EU but knowledge of interactions and collaboration with the EU are important for obtaining and maintaining marketing authorisations in the UK and the EU.
The programme will cover the current legal basis of pharmaceuticals regulation in the EU and proposed changes in pharmaceuticals legislation. The proposed changes in procedures for obtaining marketing authorisation in the EU and post-authorisation data and marketing protection will be considered. The changes in the role and responsibilities of the EMA will be discussed.
The format will provide opportunities for discussion and for sharing of concerns and experiences with our expert trainer and other delegates.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
- Understand the legal basis of the EU regulatory environment
- Discuss proposed changes to EU Pharmaceuticals legislation
- Review current and proposed procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Consider post-authorisation data and marketing protection
- Learn about proposed changes to the EMA responsibilities and function
Who should attend?
The course is designed primarily for regulatory affairs personnel, however, it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and strategic factors. It will be of interest to personnel working in:
- Regulatory affairs
- Project management
- Business planning
- Commercial management
- Labelling and artwork
- Medical information
- Manufacturing and QA
This course will cover:
Introduction of presenter and participants
Aim of course
Background
- Background to proposed EU legislation changes
- EU regulatory environment
- Proposed changes to EU pharmaceuticals legislation
Pre-submission
- Development advice
- Discussion re adaptive procedures
Submission procedures
- EU procedure for obtaining marketing authorisation and proposed changes
- Centralised Procedure (CP)
Submission procedures (continued)
- Decentralised Procedure (DP)
- Mutual Recognition Procedure (MRP)
- National procedures
Post-authorisation
- Post-authorisation data and marketing protection and proposed changes
- Post-authorisation obligations and proposed changes
Institutional and wider issues
- The EMA
- One Health
- Environmental protection
Q&A and discussion
Norah Lightowler
Lightowler Associates
Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.
Isle of Man
- SEQ Limited
- SEQ Ltd
United Kingdom
- Almac Group
- Theramex
Italy
- Skillpharma S.r.l.
Spain
- FAES Farma SA
