Drug development: from molecule to the market

Электив: «Разработка лекарств: от молекулы к рынку»
Куликов А.В., Мелихова В.С.
Начало курса 14 октября 2016г, расписание: по пятницам в 13:00
Drug development: from molecule to the market

Lecture 1
The world of pharmaceutical and biotech industry: Market, companies, risks, challenges, perspectives. Portfolio management.

Lecture 2
New trends in drug development.

Lecture 3
Early R&D Process. Stages of lead identification and validation. Computer-aided drug design.

Lecture 4
Pre-clinical testing. ADME and pharmacokinetics.

Lecture 5
Scale-up. Manufacturing, GLP, GMP.

Lecture 6
Clinical trials, approval process, protocol development, reporting.
Bioethics in drug development. Informed consent. Vulnerable groups of patients.

Lecture 7
Regulatory affairs. Drug approval process. Market access, reimbursement, tenders.

Lecture 9
Pharmacovigilance. Adverse events and post-marketing regulation.

Lecture 10
Investments for Drug development. governmental, venture and private capital. Licensing, venture fund structure and work.

Lecture 11
Pharmacoeconomics: introduction to methods and principles.