An Essential Overview of the Pharmaceutical & Biotech Industries - 1-Day Programme (London, United Kingdom - May 4, 2020) - ResearchAndMarkets.com

The "An Essential Overview of the Pharmaceutical and Biotech Industries" conference has been added to ResearchAndMarkets.com's offering.

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

Who Should Attend?

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.

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
• Strategy and the targeted product profile

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 pharmacovigilance
  • Safety reporting and signal detection
  • Evaluation and risk management plans - Periodic and drug safety update reports

Regulatory processes

• 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

Speaker

Laura Brown

Pharmaceutical QA & 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.

For more information about this conference visit https://www.researchandmarkets.com/r/tie28s