This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
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.
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.
Benefits of attending:
This course will be of particular relevance if you are involved in:
• Regulatory affairs
• Project management
• Business planning
• Commercial management
• Manufacturing and QA
• Labelling and artwork
• Medical information
• Clinical
• Pharmacovigilance
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
Registration procedures
Managing product labelling
Abridged applications
Post-authorisation obligations and strategic considerations
Safety reporting
Licence variations
Strategic considerations
Case study 3: Post-authorisation strategy discussion
Licence renewals
Norah Lightowler
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 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
| 22-23 Oct 2020 | |||
| 22-23 Oct 2020 | Cavendish Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
“Good knowledge of the regulations and good speaker”
Matteo Lapini, Regulatory Affairs Therapeutic Area Lead, Menarini Ricerche s.p.a
“Solid content, the form was good, good speaker. ”
Marion Drouet, International Product Partner, Roche
“I got what I expected. An overview of pharmaceutical legislation, speaker was great with huge knowledge. ”
Danijela Jurisic, Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices
“Overall I found this useful, some content was not so relevant, but a good general overview.”
Joanna Fitch, Regulatory Affairs Senior Manager, GSK Consumer Healthcare
“Norah was clear, open for questions and sympathetic. ”
Vanina Premus Pogacar, Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices
“Very useful course to improve the understanding of European Requirements and the different types of procedures”
Tonia Mazzarella, Regulatory Affairs, Zambon SpA
“Course content is very comprehensive, cannot recommend any additions. Presentation slides are also very thorough and appropriately referenced. Good speaker but could be more engaging as per previous comments”
Suna Horner, Associate Medical Manager, HRA Pharma UK & IE Ltd.
“The course was informative, comprehensive and interactive. The venue was fantastic and Management Forum was well organised. The entire course was well put together. Brilliant Experience!”
Evelyn Olasegha, Senior Manager Regulatory Affairs, Mundipharma Research Ltd
“The content is up to date, however, lack of detail explanation in each legislation and regulation (but understandably that it will be insufficient to do it in 2days course)”
Chin Hooi Yeo, Gx Labelling Specialist, Zentiva Group a.s.
“Very useful”
Carola Lempke, Senior Patent Attorney, AstraZeneca
“Speaker was personable, knowledgeable good place and tone. ”
Sorwar Choudhury, Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited
“Overview good”
Gregor Schaefer, Medical Therapeutic Area Specialist, Galderma International
“Nice speaker - open for discussion”
Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services
“This kind of overall training covers a lot of topics, that's why it is very interesting”
Sophie Ferruit, Scientific writer, Monachem
“Interesting and very valuable course.”
Sofie Stalmans, Regulatory Affairs, PhaRA BVBA