Preclinical: pharmacology, screening, candidate selection Safety: Genotoxicity battery, single and repeated dose toxicity studies, NOAEL, NOEL, safety margins/toxicokinetics, safety pharmacology studies, Herg channel and related studies, carcinogenicity studies, ADME studies, CYP profiling Manufacturing: drug substance: stability, impurities, particle size, bulk density; drug product: stability, packaging, dissolution profiles, planning for drug supplies Marketing for developers: the all-important target profile; sales forecasting, risk adjusted NPV calculation; basic health economics Clinical Pharmacology: assays, basic pharmacokinetic concepts (half-life, Cmax. Css, AUC), starting dose selection, single and multiple dose studies, special studies (food, gender, elderly, children, renal/hepatic impairment, drug-drug interactions), use of biomarkers in early development, bioequivalence studies, QTc studies, population pharmacokinetics as a powerful approach, basic pharmacogenomics. Statistics and Data Management: basic statistics, testing for normally and non-normally distributed data, p values, confidence intervals, sample size estimation, interim analysis, data and safety monitoring boards, data management for clinicians Clinical Research Guidelines: GCP, informed consent, monitoring, standard operating procedures, auditing, the Investigators Drug Brochure Clinical Trial design: phase I studies, Phase IIa, Phase IIb, Phase III, combined Phase II/III, international study issues Drug Safety: SAE reporting, Periodic Safety Update Reports, Pharmacovigilance, SmPC sections Regulatory: ICH guidelines, 21CFR, IND, IMPD, NDA/MAA submission (emphasising the Common Technical Document), writing the SmPC, Orphan Drug regulations, regulatory advice meetings in EU and US. Accelerated approval. Project Management: Overseeing activities across disciplines; project planning/use of Gannt charts Teamwork: issues with working in teams in general and globally, motivation.