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.
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.
CASE STUDY 1
Impact of Brexit
CASE STUDY 2
Generic applicationsPost-authorisation obligations; pharmacovigilance, variations and renewals including discussion on the impact of Brexit
Pharmacovigilance and GCP inspections
Licence variationsCASE STUDY 3
Renewals
Managing and supporting a regulatory affairs department
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.
| 14-15 Mar 2019 | |||
| 14-15 Mar 2019 | Rembrandt Hotel, London | GBP 1,299.00 EUR 1,819.00 USD 2,026.00 + VAT @ 20.00% |
Enrol now |
| 23-24 Sep 2019 | |||
| 23-24 Sep 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
“[The speakers were] very knowledgable. ”
Therese Metzsch, Senior Assistant, Ferring Pharmaceuticals A/S
“Madam Norah Lightowler is an excellent speaker... Presentation was great, everything was clear. The speaker was really nice and she gave a great input about this whole industry and RA.”
Valentina Cabula, eCTD Specialist, Xellia Pharmaceuticals ApS
“Norah [the speaker] is a very nice and professional person ”
Sarah Bourgin, Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl
“Interesting and informative. Good speaker, very knowledgable.”
Marissa Ashfield, Pharmacovigilance - AO, Veterinary Medicines Directorate
“Very thorough run-through of all RA procedures and on-going maintenance”
Elliot Statham, Business Development Specialist, Creo Pharma Ltd.
“The course, presentation and speaker were all brilliant”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“Useful course to get a broader knowledge and insight about the position of the RA associate.”
Dusan Ilic, RA Associate, Mallinckrodt Medical BV
“Very interesting content and well explained by speaker”
Charlotte Sellwood, Regulatory Information Executive, Bayer PLC
“All very good”
Karen Scott, Regulatory Affairs Team Administrator, Mundipharma Research Limited
“The facilities and the event organisers were very good, really welcoming and polite. The venue was a great choice and the refreshments offering was great! Thank you!”
Daniel Akhtar, RA Business Support Specialist, Abbvie Ltd.
“The course was detailed and interesting. I found the speaker to be engaging and friendly.”
Bethan Farley, Product Specialist - Global Technical Management, Norgine Ltd
“Interesting and very enjoyable”
Rupinder (Ruby) Bhelay, PA/Team Administrative Assistant - Regulatory Affairs & Quality, Baxalta UK Ltd – now part of Shire Pharmaceuticals (4th Floor)
“The content was packed with relevant information leaving me confident in my role”
Christina Obafemi, Regulatory Affairs Specialist II, Teva UK Limited
“Very useful and enjoyable”
Hannah Lee, Regulatory Affairs Student Placement, Mundipharma Research Limited
“I would definitely recommend the course for people with very basic knowledge on Regulatory Affairs in Europe. All expected topics were covered sufficiently (even some global regulatory topics). Norah was very clear and happy to answer questions.”
Beata Posa, Access to Documents Coordinator, EMEA
“Very informative”
Roshini Nellailingam, Regulatory Affairs Manager, Emas Pharma Ltd
“It was a good material, well present and I enjoy the discussions about the context”
Barbara Costa, Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited
“I like the content and also the presentation of the slides. Norah was a very pleasure person to explain and clear in everything she was saying. ”
Barbara Costa, Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited
“Good introductory course. Good presentation by a knowledgeable speaker. Interactive case study sessions. Pleasant environment.”
Edouard Guillabert, Director & Consultant, GalenAuxi Ltd
“As someone who has no experience of what the course included, I was able to make some sense in relation to documents that my colleagues write”
Joanne Zaninovic, Client Account Assistant, Trilogy Writing & Consulting GmbH