Optimising “time-to-market” is an increasingly critical requirement for pharmaceutical companies challenged by shrinking pipelines. Tighter standards imposed by regulatory authorities has almost certainly contributed to this. Are you looking for ways to improve your regulatory affairs activities and optimise drug submission procedures? This interactive 2-day course will provide a clear understanding of the EU regulatory structure and ensure your submissions meet the standards required by the regulators.

Who Will Attend?
Those moving into regulatory affairs from other areas within a pharmaceutical company such as Pharmacists, Clinical Trials or Marketing professionals. Anyone wishing to update their knowledge on European regulatory affairs or those moving into regulatory affairs from other areas within a pharmaceutical company.

Course Leader
Norah M. Lightowler, BPharm, LLB, MRPharmS, FBIRA, is a partner in Lightowler Associates, regulatory consultants to the pharmaceutical industry. 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 regulatory control systems, including requirements, procedures and strategy.

Lightowler Associates is an independent consultancy offering expert regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They offer a comprehensive regulatory service from development, through registration to maintenance of marketing authorisations.

Dr Richard Lee, B.Sc, Ph.D MBIRA, independent consultant on pharmaceutical registration issues
> Early career – Research and Development in the pharmaceutical industry, initially with Wellcome’s veterinary division
> Lately – Project Leader and head of pharmacokinetics, metabolism and assay development at SmithKline & French (now SB)
> Appointed UK representative on the Safety Working Party of the CPMP
> For 4 years was European delegate to a number of ICH Expert working Groups, with special interest in toxicokinetics, toxicity of impurities and preclinical development programmes for biotechnology products

Registration required:

Yes

Free:

No