What are the most significant current issues shaking and shaping today's pharmaceutical industry? The business environment and legal framework pertaining to the pharmaceutical industry continue to change rapidly as they are constantly challenged by competition, politics and new technological possibilities. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.
This course provides a broad and practical understanding of the "hot topics", and will present and analyse these topics from a scientific, legal and policy perspectives. The hot topics are:
- Scientific trends - Scientific breakthroughs that impact the pharmaceutical industry and create new business opportunities
- Biosimilars & Antibodies - New approval pathways, guidelines & regulatory requirements
- Data & market exclusivities - Legislation and political debates
- Individualized medicine - Threats, challenges and opportunities
- New markets - How to deal with the emerging Asian markets?
- Clinical trials - New challenges posed by increasing international competition
- Patents & competition law - Recent pharma-related case law
- Paediatric extensions & SPCs - New developments & case law
- Public Private Partnerships (PPPs) - An increasingly important model of co-operation
- Counterfeit Medicines - Buying and selling pharmaceuticals in cyberspace beyond established quality control systems?