This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations. It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.
Benefits of Attending
This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post authorisation strategies and obligations.
It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements
This course is for you, particularly if involved in:
EU Regulatory Environment: Legal basis
Impact of Brexit
Development Strategy and Pre-Submission Activities
Case study 1: Submission Requirements
The Common Technical Document (CTD)
Applying for a Marketing Authorisation in the EU
Case Study 2: Registration strategy: Will Brexit alter this?
Managing Product labelling
Managing product labelling
Post Authorisation Obligations and Strategic Considerations
Case study 3: Post Authorisation Strategy discussion: will Brexit alter this?
Norah Lightowler (29-30 Apr 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.