Drug discovery and development process – from target validation to clinical phase
Stability, impurities and degradation products – from identification to justification
Regulatory documentation – IND, DMF, QOS, CTD, ERA
Regulatory advice – deficiency letters, expert statement, regulatory strategies
Environmental Risk Assessments – a new approach to prepare ERAs
In silico toxicology assessment – from impurity profiling to ERA
Commercial evaluation of drug development projects – from idea to market
Quality Management Support – from control to audit
Audits – GMP and supplier audits
Support for CRO selection – from request to match
Statistics – an inevitable tool in drug development
IP management – from claims to product portfolio
RD&C network – from academia to industry
Publication & scientific talks – RD&C’s scientific activities