The ‘Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations: Expert Overview’ training course is a key course developed by DIA in Europe. This course provides a comprehensive description and discussion of the regulatory environment. The course focuses on Europe but also looks at regulations in other regions including the USA and Japan.
This is a unique opportunity to learn, understand and discuss the main aspects of drug regulations in Europe directly from key European Regulators and from the large experience in the pharmaceutical industry and to acquire key recommendations for a successful implementation of your regulatory strategy and operations.
- Drug regulations
- Role of regulatory affairs in drug - development / approval / marketing
- Efficient interactions between regulatory agencies and the pharmaceutical industry
- Regulatory strategy
- Key differences of international regulatory environments
Who should attend?
This course provides an excellent education and training tool, not only to participants in the postgraduate course, but also to experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:
- Regulatory affairs
- Clinical drug development
- Preclinical drug development
- Pharmaceutical development
- Drug quality control
- Quality assurance and compliance
- Regulatory writing
- Drug import / export
At the conclusion of this course, participants should be able to:
- Define the drug legislation and regulation with focus on the EU
- Identify the key function of regulatory affairs during the different phases of a drug life cycle
- Assess information from the extensive experience of experts of regulatory agencies and industry
- Set up successful regulatory strategies