This programme will give you an invaluable overview, refresher and update on the pharmaceutical and biotechnology industries, from discovery of the molecule through development to marketing. It will provide a step-by-step understanding of the main areas of drug development and will discuss the roles and responsibilities of key staff involved. You will be given a comprehensive glossary of the most commonly used industry terms, which will be an invaluable reference to help you get to grips with the technical terminology and jargon.
Why you should attend
- Increase your understanding of the pharma/biotech industries
- Develop your knowledge of the stages of drug development from drug discovery through to marketing
- Get to grips with the phases of clinical trials, regulatory processes and pharmacovigilance requirements
- Understand the roles and responsibilities of key departments and how they work together
- Demystify the technical terminology and jargon
How the pharma/biotech industries develop medicines
- Overview of drug development
- Framework of the industry – research, development and manufacture of pharma products on an international level
- Difference between pharma and biotech drug development - Drug discovery
- Non-clinical/pre-clinical – the importance of examining safety - Technologies and innovations across the industry
- Strategy and the targeted product profile
Demystifying the jargon and terminology
Roles and responsibilities of the people in the pharma/biotech industries
- Phases of clinical research – phase 1 to phase IV and range of clinical trials
- Setting up and running of clinical trials
- Quality of the data – monitoring, auditing and compliance with GCP innovations in running clinical trials
- Understanding pharmacovigilance
- Safety reporting and signal detection
- Evaluation and risk management plans – Periodic and drug safety update reports
- Overview of regulatory submissions and approval procedures for pharma/biotech products
- EU and FDA accelerated procedures
- The importance of ICH
- ICH and the electronic Common Technical Document (eCTD)
- The EU Clinical Trial Regulation
- Update on the impact of Brexit
Commercial considerations for how medicines are marketed and sold
- Marketing terminology and activities
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
All those wanting to achieve a better understanding of how the pharma/biotech industries work. The course will be particularly helpful for those wanting to understand what other departments do, for new staff working in the industry and for non-scientific and administrative personnel.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.