Kursusprogram
Dag 1
Welcome and Introduction
Introductions to the Pharmaceutical Industry
- General introduction to the pharmaceutical industry and its various definitions
- The differences between pharma and biotech
- General introduction to global and regional pharmaceutical innovation and development
Preparation of Drug Substance
Research & Non-clinical Development
- Industry Challenges
- Translational Medicine
- The Drug Discovery Process
- Preclinical Development
Pre-clinical/non-clinical testing
Introduction of Assignement II & Group Work
Break
Clinical Development
- General introduction to and definitions of clinical development
- Phase I. II. III & IV trials
Clinical Testing
Introduction of Assignment III & Group Work
Registration
- Roles and responsibilities of Regulatory Affairs (RA)
- Getting a drug on the market
- ICH International Conference of Harmonisation
- Life Cycle Management
- What is hip and hot - and what is coming up
Lunch
Registration file - Marketing Authorisation Application
Introduction of Assignment IV & Group Work
Pharmacovigilance
- What is Pharmacovigilance?
- Why is it needed?
- What and how?
- Goals of Pharmacovigilance?
Production / Manufacturing
- Drug Development
- Good Manufacturing Practice
- Lundbeck Supply Chain
- Examples; How to make a tablet, How to make a blister pack
- Doing it effectively - LEAN
Break
Sales & Marketing
- The sales process consists of interpersonal interaction. It is often done by a one-on-one meeting
- It's anything that engages you with the decision maker on a personal level rather than at a distance
- Pharmaceutical sales are direct towards the decision maker but "indirect" towards the patient
Marketing & Sales
Introduction to Assignment V & Group Work
Presentation of Group Work
Evaluation File for Registration
Future Challenges and Possibilities in the Pharmaceutical Industry
Conclusion