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Regulatory Affairs for Support Staff
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.
Course overview
Working in pharmaceutical regulatory affairs is a complex role, with involvement in not only the drug development stages but also post drug-approval activities and marketing.
This interactive course, designed specifically for those working in a support staff role, provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.
Participants will gain an overview of the 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.
The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the potential impact of Brexit. The course will provide a thorough grounding in the subject of regulatory affairs and enable support staff to perform more effectively.
Discussion sessions and the use of case studies throughout the two days will help consolidate learning.
Benefits of attending:
- Understand the background of EU law – regulations, directives and guidelines
- Consider the potential impact of Brexit
- Gain an understanding of the Common Technical Document n Discuss how to apply for a marketing authorisation in the EU – the centralised, decentralised and mutual recognition procedures
- Clarify post-authorisation obligations – pharmacovigilance, variations and renewals
- Assess the impact of the EU Clinical Trial Regulation
Who should attend
This course is designed for anyone working in regulatory affairs including administrators, assistants 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 provide support to the regulatory procedures and activities.
Programme - Day one
- Impact of Brexit
- The internet/publications
- Approvals and withdrawals
- Drug discovery
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies – Phase I to IV
- Registration
CASE STUDY 1
The EU Clinical Trials Directive and new Clinical Trial Regulation
- What is the process for running clinical trials in Europe?
- What are the processes?
- Structure and content of a CTD
- Impact of Brexit
Programme - Day two
- The EU centralised procedure
- Decentralised procedure
- Mutual recognition procedure
- National procedures
CASE STUDY 2
Generic applications- Requirements
- How the process works
- Impact of Brexit
- Company core data sheets
- Updates to summary of product characteristics
- What to expect
- Type I and Type II variations
- Procedures and timelines
CASE STUDY 3
Renewals
Managing and supporting a regulatory affairs department- Things to consider
- Maintaining oversight
Presenter
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.
Book now
| 19-20 Mar 2020 | |||
| 19-20 Mar 2020 | Holiday Inn London - Kensington Forum, London | GBP 1,299.00 EUR 1,819.00 USD 2,026.00 + VAT @ 20.00% |
Enrol now |
| 29-30 Sep 2020 | |||
| 29-30 Sep 2020 | Rembrandt Hotel, London | GBP 1,299.00 EUR 1,819.00 USD 2,026.00 + VAT @ 20.00% |
Enrol now |
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Previous customers include...
- Actelion Pharmaceutical Ltd
- Alcon
- Allergan
- Allergan Ltd
- Allergan UK Limited
- Almus Pharmaceuticals Ltd
- Azad Pharma AG
- Bayer Consumer Care AG
- BD Medical – Pharmaceutical Systems
- Boehringer Ingelheim Animal Health GmbH
- Boehringer Ingelheim Pharma
- Celgene Europe Ltd
- Dafra Pharma International
- Delaval NV
- Ferring Pharmaceuticals A/S
- Fisher Clinical Services
- Fresenius Kabi AB
- Gilead Sciences
- Hoffman La Roche
- Ipsen Biopharm Ltd
- NDA Regulatory Science Ltd
- Novella Clinical, a Quintiles Company
- Nutriad International BV
- Parapharm Development LTD
- Research and Markets
- RTE
- RWS Group
- SCHWARZ PHARMA LTD
- Takeda GmbH
- Xellia Pharmaceuticals ApS
“Highly recommended course for anyone wishing to learn more about their involvement within the regulatory affairs team at your particular company. The speaker, Norah, was very effective in her presentations and included each delegate and was able to highlight how certain areas were specific to them.”
James Smith, Regulatory Affairs Officer, Kyowa Kirin International
“I spent a nice moment, and I come back with a lot of information, which is very motivating for my job. ”
Audrey Chopard-Lallier, Administrative Assistant, Debiopharm International SA
“[The speakers were] very knowledgable. ”
Therese Metzsch, Senior Assistant, Ferring Pharmaceuticals A/S
“Norah [the speaker] is a very nice and professional person ”
Sarah Bourgin, Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl
“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
“Useful course to get a broader knowledge and insight about the position of the RA associate.”
Dusan Ilic, RA Associate, Mallinckrodt Medical BV
“Interesting and informative. Good speaker, very knowledgable.”
Marissa Ashfield, Pharmacovigilance - AO, Veterinary Medicines Directorate
“Very interesting content and well explained by speaker”
Charlotte Sellwood, Regulatory Information Executive, Bayer PLC
“The course, presentation and speaker were all brilliant”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“Very thorough run-through of all RA procedures and on-going maintenance”
Elliot Statham, Business Development Specialist, Creo Pharma Ltd.
“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.
“All very good”
Karen Scott, Regulatory Affairs Team Administrator, Mundipharma Research Limited
“The course was detailed and interesting. I found the speaker to be engaging and friendly.”
Bethan Farley, Regulatory Conformance Manager, 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)
“Very informative”
Roshini Nellailingam, Regulatory Affairs Manager, Emas Pharma Ltd
“The content was packed with relevant information leaving me confident in my role”
Christina Obafemi, Regulatory Affairs Specialist II, Teva UK Limited
“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
“Very useful and enjoyable”
Hannah Lee, Regulatory Affairs Student Placement, Mundipharma Research Limited
“It was a good material, well present and I enjoy the discussions about the context”
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
“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
“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