SEE THE BIGGER PICTURE...with PTI's How Drugs are Developed self-study course
UNBEATABLE, CONVENIENT TRAINING...that forms a reference guide useful to you and your company long after you finish studying
ASK QUESTIONS...at any time during the course via telephone and email helplines
EACH MODULE IS SENT TO YOU...offering you the chance to study at the most convenient time and place
A practical course for anyone who needs to understand how the many processes that contribute to successful development of a new medicine works!
Science, medicine, law and business awareness – the successful development of a medicine demands a wide range of expertise. How does it all fit together?
How Drugs Are Developed answers the question with a detailed but accessible overview of the pharmaceutical industry, from the birth of an idea throughout the development program leading to a successful drug registration. It also describes the post marketing obligations relating to pharmacovigilance and the continuing lifecycle maintenance and management activities to ensure the product return can be optimised.
Over 10 weeks, the course explains drug development and the connections between the functions involved. How does inspiration from a molecular biologist eventually become a drug used in humans for the first time in clinical trials? How does a concept move from the initial research chemist via the toxicologist, the clinician and the economist? How drugs Are developed presents the bigger picture. See the industry from the inside and gain an understanding of the factors that affect product development. This will allow you to make your own informed decisions and so improve your contribution to your own role.
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?
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
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals