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.
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 email@example.com 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.
European Law – Regulations, Directives
Where can we find the information on regulatory affairs, approvals, withdrawal?
The drug development process from discovery to product approval
CASE STUDY 1
Seeking scientific advice in Europe
The Common Technical Document
The European Medicines Agency
The EU Centralised Procedure
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.