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LIVE ONLINE MASTERCLASS - EU Pharmaceutical Legislation and Regulatory Procedures in the EU and UK

12th & 13th September 2024

Norah Lightowler is the owner of Lightowler Associates, regulatory consultants to the pharmaceutical industry offering expert advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. She has wide experience in the pharmaceutical industry including research, as a regulator with the UK regulatory authority and in regulatory affairs as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European requirements, procedures, and strategy. With her extensive background and expertise, she is exceptionally well-equipped to provide valuable regulatory consulting services to pharmaceutical companies aiming to navigate the complexities of the European market. Her combination of legal, pharmacy, and regulatory knowledge positions her as a valuable resource for companies seeking guidance on compliance, market entry, and strategic planning.

Course Title :

  • UNDERSTANDING EU AND UK PHARMACEUTICALS REGULATIONS
  • CURRENT LANDSCAPE AND FUTURE PERSPECTIVES

Course overview :

The course provides an overview of current EU pharmaceuticals legislation with discussion of proposed changes. Procedures available for obtaining marketing authorisation approval for human pharmaceuticals in the EU and post approval obligations will be outlined and since leaving the EU, available procedures in the UK. Participants will receive PDFs of PowerPoint material used in the sessions. Cases will be available for participants to discuss, and to consolidate the main points in presentations. The course will be interactive with questions taken during presentations as well as Q & A sessions at the end.

Key topics:

  1. 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.
  2. 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.
  3. UK Regulatory Environment
    • Insight into the regulatory landscape in the UK post-Brexit.
    • Understanding any regulatory divergence between the UK and the EU.
  4. Knowledge of Available EU & UK Procedures
    • Detailed explanation of procedures for obtaining marketing authorization approval in both the EU and the UK.
    • Comparison of regulatory pathways and requirements.
  5. Post Authorization Action and Obligations.
    • Overview of post-approval obligations for pharmaceutical companies in the EU and the UK.
    • Discussion of pharmacovigilance, labelling 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.


Participants will benefit from gaining insights into regulatory affairs, and compliance.