Registration - Current And Proposed Changes To Pharmaceutical Legislation Procedures In The EU And UK
Current And Proposed Changes To Pharmaceutical Legislation Procedures In The EU And UK
LIVE ONLINE TRAINING
16th -17th June 2025
Who is Your Trainer
NORAH LIGHTOWLER
Educationist, Professor & Instructor
Norah Lightowler, LLB, BPharm, MR PharmS, FTOPRA, is the owner of Lightowler Associates, a regulatory consulting firm specializing in guiding pharmaceutical companies entering the European market for human pharmaceuticals.
With extensive experience in research, regulatory bodies, and industry, she brings a comprehensive understanding of European regulatory affairs. She has worked as a regulator with the UK authority and served as Associate Director of European Regulatory Affairs at an international pharmaceutical company.
Norah’s expertise in legal, pharmacy, and regulatory matters makes her a valuable resource for companies navigating compliance, market entry, and strategic planning. Additionally, her experience in organizing and presenting courses on European regulatory requirements and procedures reflects her commitment to knowledge sharing and industry standards.
With her credentials and proven track record, Norah Lightowler and Lightowler Associates are highly sought after by pharmaceutical companies aiming for regulatory compliance and successful market entry into Europe
COURSE OVERVIEW
This course offers participants a comprehensive understanding of the current European Union (EU) and United Kingdom (UK) pharmaceuticals regulations, including discussions on proposed changes and the impact of Brexit. Participants will explore the procedures for obtaining marketing authorization approval for human pharmaceuticals in both the EU and the UK, along with post-approval obligations. The course will be interactive, featuring case studies for discussion and opportunities for OCA sessions.
KEY TOPICS
- Overview of Current EU Regulatory Environment
- Understanding the regulatory framework governing the pharmaceutical industry in the EU.
- Discussion of key regulations and directives shaping the industry landscape.
- Proposed Changes in EU Pharmaceuticals Legislation
- Examination of proposed changes and regulatory developments affecting pharmaceutical companies in the EU.
- Analysis of potential implications for stakeholders.
- UK Regulatory Environment
- Insight into the regulatory landscape in the UK post-Brexit.
- Understanding any regulatory divergence between the UK and the EU.
- Knowledge of Available EU s UK Procedures
- Detailed explanation of procedures for obtaining marketing authorization approval in both the EU and the UK.
- Comparison of regulatory pathways and requirements.
- Post Authorization action and Obligations
- Overview of post-approval obligations for pharmaceutical companies in the EU and the UK.
- Discussion of pharmacovigilance, labeling updates, and other regulatory responsibilities.
BENEFITS OF ATTENDING
- Gain comprehensive knowledge of key topics and regulatory frameworks in the EU and the UK.
- Opportunity to discuss issues with the presenter and other participants, fostering knowledge sharing and networking.
- Enhance understanding of regulatory procedures and compliance requirements.
- Stay updated on proposed changes and future trends shaping the pharmaceutical industry.