Regulatory Affairs for Support Staff

This two day in-house training programme provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support role.

In-house Training Services and Consultancy

This two day in-house training programme, will provide your team with an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support role. They will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products. The course will provide a thorough grounding in the subject of regulatory affairs and enable your team to perform their roles more effectively.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

European Law – Regulations, Directives

Where can we find the information on regulatory affairs, approvals, withdrawal?

  • The Internet
  • Publications
  • Approvals and withdrawals

The drug development process from discovery to product approval

  • Drug discovery
  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies – Phase I to IV
  • Registration

CASE STUDY 1

  • The EU Clinical Trials Directive and Regulation*
  • What is the process for running clinical trials in Europe?

Seeking scientific advice in Europe

  • What are the processes?
  • How are the procedures organised?

The Common Technical Document

  • Structure and content of a CTD

The European Medicines Agency

The EU Centralised Procedure

Recommended trainer

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 twentieth year of successful business. She 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.