#pharmaceutical industry overview
An Essential Overview of the Pharmaceutical Industry
This programme will give you an invaluable overview of the Pharmaceutical industry, 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.
Who should attend
All those wanting to achieve a better understanding of how the Pharmaceutical Industry works. 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.
Why you should attend
- Increase your understanding of the Pharma industry
- Develop your knowledge of the stages of drug development from dug discovery through to marketing
- Get to grips with the phases of Clinical Trials, Regulatory Processes and Pharmacovigilance Requirements
- Understand the role and responsibilities of key department and how they work together
- Demystify the technical terminology and jargon
How are drugs developed?
- Overview of drug development and why we patent drugs
- Drug discovery how to identify
- New Chemical Entities ( NCE )
- Non-clinical / pre-clinical development of lead compounds
Demystifying the jargon and terminology in the pharma industry
What are the roles and responsibilities of the people in the pharmaceutical industry?
Clinical trials and how they advance a drug to market
- What happens at each phase of clinical research?
- Ensuring the quality of the data: monitoring, auditing and working to ICH
- What is safety reporting, signal detection, evaluation and risk management?
- Overview of regulatory submission and approval procedures
- Understanding the ICH process
- The electronic Common Technical Document (eCTD), and the impact of the EU Clinical Trial Regulation
Potential impact of Brexit to the pharma industry
- How are drugs marketed and sold?
Dr Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University of Cardiff and Course Director of the MSc Regulatory Affairs, TOPRA. Laura has many years’ experience in the Pharmaceutical Industry. She has worked for several companies including Glaxo Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department.
Dr Laura Brown MBA. BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR. is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA. She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. She has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP. is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. She is co-author of several books on management including ‘Developing the Individual’, ‘The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.
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Previous customers include.
- (MHRA) Medicines & Healthcare Products Regulatory Agency
- Abbott EPD
- Abbott Products Operations AG
- Actavis Plc
- Allergan UK Limited
- BD Pharmaceutical System
- Becton Dickinson UK Ltd (Oxford)
- Chiesi Farmaceutici SPA
- Chugai Pharma UK Ltd
- Debiopharm International SA
- Digiweb Ltd
- Eisai Limited
- FFG-Austrian Research Promotion Agency
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Mundipharma Research Limited
- Pharmacovigilance Matters Limited
- Pliva Croatia d.o.o.
- Shire Pharmaceuticals
- Sunovion Pharmaceuticals Europe
- Teva Pharmaceuticals Ltd
- Toxikon Europe NV
- UCB Biopharma SPRL
- UCB BIOSCIENCES GmbH
- UCB Pharma SA