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.
27-28 Sep 2022
Working in pharmaceutical regulatory affairs is a complex role, with involvement in the drug development stages to post-approval obligations and marketing.
This interactive course is designed for those working in a support staff role and 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 the EU and the regulatory activities that need to be complied with to keep products on the market. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical market in Great Britain and Northern Ireland will be discussed.
The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the impact of Brexit in these areas. 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:
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 will also be of value to those who interface with the regulatory affairs function or provide support to the regulatory procedures and activities.
Norah Lightowler (More...)
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.
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
27-28 Sep 2022 Live webinar 09:15-17:00 UK (London) |
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27-28 Sep 2022 Live webinar 09:15-17:00 UK (London) |
GBP 1,099 899 EUR 1,579 1,299 USD 1,786 1,474 Until 23 Aug* |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.