How Drugs Are Developed

This unique distance learning course gives you unbeatable, convenient training and forms a reference guide useful to you and your company long after you have finished studying. You will gain an idea of how the three key parts, quality, safety and efficacy of medicine is evaluated. You will receive comprehensive information about the key aspects of development of a medicine:

✓ The range of drugs
✓ Drug targets
✓ Lead generation
✓ Lead optimisation
✓ Key development processes and their optimal management
✓ Regulatory submissions for human trials
✓ Regulatory submissions for approval to market
✓ Clinical development
✓ Pharmacovigilance obligations
✓ Post-marketing activity and management

For pharmaceutical specialists

This course will show you how everyone fits into the R&D pipeline. Drug development relies upon scientific expertise, clinical excellence, close atention to the legal requirements and a fully informed network of sales representatives, marketing specialists and management. It's about connections - who, what, where and why?

For non-specialists

How Drugs Are Developed offers a unique guide to the pharmaceutical industry. You need to understand your colleagues and your clients. This course gives you a complete grounding in the drug development business and lets you see the industry from the inside.

Don't forget, you can ask questions at any time during the course via the telephone and email helplines.

Ann now runs her own Regulatory Affairs Consultancy. She has worked in the field of regulatory affairs for over 20 years, with further experience in the pharmaceutical industry in quality assurance prior to this. She has worked for various companies in a wealth of roles, which have involved all aspects of regulatory, with projects relating to all stages in a product lifecycle from early clinical development through to working with established large commercially successful brands, managing regulatory affairs and providing both strategic advice and operational support. Expertise in working in roles such as managing a major global product and site rationalisation programme, a company name change for a multinational company in various markets, development of company training schemes and introducing SOP systems and procedures, and with initiatives such as readability testing, and legal status switching of medicines.

For more information about Ann, please click here