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.
14-15 Mar 2019
& 23-24 Sep 2019
GBP 1,299 1,099 *
EUR 1,819 1,539 *
USD 2,026 1,714 *
* When you book before 21 Jan
By attending this course you 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 licence variations and the commercial aspects of pharmaceutical products. The potential impact of Brexit will also be discussed. The course will provide a thorough grounding in the subject of regulatory affairs and enable you to perform in your role more effectively.
Benefits of attending:
This course is specifically designed for anyone working in regulatory affairs including personal assistants, secretaries, administrators 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 who provide support to the regulatory procedures and activities.
European Law – Regulations, Directives
Where can we find the information on regulatory affairs, approvals, withdrawal?
The drug development process
CASE STUDY 1
Seeking scientific advice in Europe
The Common Technical Document
The European Medicines Agency
Impact of Brexit
Applying for a Marketing Authorisation in the EU with discussion on the impact of Brexit
CASE STUDY 2
Managing product labelling
Post-authorisation obligations; pharmacovigilance, variations and renewals including discussion on the impact of Brexit
Pharmacovigilance and GCP inspections
CASE STUDY 3
Managing and supporting a regulatory affairs department
Norah Lightowler (14-15 Mar 2019)
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.