In the dynamic and highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where a comprehensive understanding of pharmaceutical regulatory affairs is invaluable.
It is important that companies are aware of proposed changes to pharmaceutical legislation in the EU and the potential impact on company planning and strategy.
The EU (European Union) on 23rd April 2023 published proposed changes to pharmaceutical legislation. Discussions between the EU Commission, the MS (Member State) and all stakeholders are ongoing. Review by the European Parliament and the EU Council is required before ratification and implementation which is unlikely to be implemented before 2025/2026.
Developing products is a lengthy process and the cost of developing new and modified products is increasing. It is therefore important to be aware of procedures and timelines for obtaining marketing authorisations and importantly to know what if any post approval data and marketing protection will be available.
The programme will cover current pharmaceuticals legislation in the EU. The background to the proposed changes in pharmaceuticals legislation will be outlined with discussed in the relevant sections including proposed changes to procedures for obtaining marketing authorisation in the EU, and post-authorisation data and marketing protection criteria and periods.
The UK is no longer a member of the EU but knowledge of interactions and collaboration with the EU and other regulatory agencies are essential for obtaining and maintaining marketing authorisations in the UK.
The format will provide opportunities for discussion and for sharing of concerns and experiences with our expert trainer and other delegates.
Benefits of attending
- Understand the legal basis of the EU regulatory environment
- Discuss the background to and the 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
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Speakers
Ms Norah Lightowler,
Lightowler AssociatesNorah 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 twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, 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.
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 in obtaining and maintaining marketing authorisations. 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
