This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
20-21 Apr 2020
& 22-23 Oct 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 13 Mar
Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money.
This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well as discussing the format for presentation of data, the registration procedure and post-authorisation strategic considerations and obligations.
There will be a number of case study sessions throughout the two days to explore options and strategies for these key regulatory activities, which will provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.
Benefits of attending:
The programme will be of value to regulatory affairs personnel and also to those who interact with regulatory personnel in order to understand action timelines and information requirements. It will be particularly relevant to all those working in:
Welcome and introduction
EU regulatory environment: legal basis
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 discussion
Managing product labelling
Post-authorisation obligations and strategic considerations
Case study 3: Post-authorisation strategy discussion
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.
|20-21 Apr 2020|
|20-21 Apr 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 13 Mar*
|22-23 Oct 2020|
|22-23 Oct 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code