This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
19-20 Mar 2020
& 29-30 Sep 2020
Working in pharmaceutical regulatory affairs is a complex role, with involvement in not only the drug development stages but also post drug-approval activities and marketing.
This interactive course, designed specifically for those working in a support staff role, provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.
Participants will gain an overview of the 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.
The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the potential impact of Brexit. The course will provide a thorough grounding in the subject of regulatory affairs and enable support staff to perform more effectively.
Discussion sessions and the use of case studies throughout the two days will help consolidate learning.
Benefits of attending:
This course is designed for anyone working in regulatory affairs including administrators, assistants and any member of support staff wishing to gain a greater understanding of regulatory affairs in the pharmaceutical industry.
It is also suitable for those who interface with the regulatory affairs function and provide support to the regulatory procedures and activities.
CASE STUDY 1
The EU Clinical Trials Directive and new Clinical Trial Regulation
CASE STUDY 2Generic applications
CASE STUDY 3
RenewalsManaging and supporting a regulatory affairs department
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 twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, 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.