Tailor made courses are designed to provide basic and essential concepts for the understanding of the drug development process. It further enables to discuss together the key parameters and critical decision taking points in the process of ethical drug development.
An example from past course:
- Research and development processes of ethical drugs – basic concepts and variable R&D processes
- Drug- Definition of content, requirements and regulations
- Organization, management and supervision of R&D processes
- Preparation of Screening Architecture – Hand-on experience
- Minimal Strategies and empiric and virtual screening systems
- Selection, revocation and advancement of Hits and Leads
- Pharmacological models in vitro and in animals
- Decision making and risk management in the screening and selection processes
- From Selection Candidate to clinical studies and registration
- Pre-clinical development – Requirements, processes and their implementation
- CMC, Formulation and Drug Product design
- From animal to Human- Completion of the requirements for clinical trials
- Clinical trials – Concept, design and regulation
- GCx, Quality and Regulatory affairs
- Pharmacokinetic and metabolic principles and their meaning during the development processes
- Linear and matrix outline for project management inside and outside of the company – organization, supervision, management and change control
- Preparation of development plan and budget- Hands on experience