The pharmaceutical and biotechnology industries are both complex and developing at a rapid pace. This intensive one-day course will give you an invaluable overview, refresher and update on all the important aspects from discovery of the molecule through development to marketing. The interactive programme will provide a step-by-step understanding of the main areas of drug development and will discuss the roles and responsibilities of key departments and how they work and interact together.
There will be interactive discussion sessions throughout the day, led by our expert course leader, and you will come away with a good knowledge of the structure and function of these industries.
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
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
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
Demystifying the Jargon and Terminology
Roles and Responsibilities of the People in the Pharma/Biotech Industries
Clinical Trials
- 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
Pharmacovigilance
- Understanding safety reporting and signal detection
- Definitions and periodic and drug safety update reports
Regulatory Processes
- Overview of regulatory submissions and approval procedures for pharma/biotech products including EU and FDA procedures
- The importance of ICH including the electronic Common Technical Document (eCTD)
- The EU Clinical Trial Regulation
- Commercial Considerations for how Medicines are Marketed and Sold
Marketing terminology and activities
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr 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.
Who Should Attend
This event will be of interest to all those looking to develop their knowledge of how the pharma/biotech industries work. It 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.
