Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA.
Identify the main legislative instruments relating to medicinal products in both the EU and USA.
Understand the main phases of the drug development process and be aware of the regulatory requirements that apply.
Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA.
Identify post-marketing regulatory activities in both the EU and USA.
This session gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.
The life-cycle of a drug
This session looks at the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies and gives a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and introduces some of the special difficulties associated with paediatric trials.
Registering a drug
This session looks at the regulatory requirements during the nonclinical studies phase as well as the salient points of Good Clinical Practice. It also introduces the regulatory processes involved in gaining marketing authorisation in the EU and the USA. The session also introduces the learner to orphan drugs, line extensions, generics, naming conventions and compassionate use.
After marketing approval
This session explores post-marketing approval activities, including variations and supplements, line extensions and pharmacovigilance, GMP, basic patent law in the EU and USA, marketing issues, advertising and generics.
Multiple-choice mastery assessment.