Drug development of various types of biologic products is a complex and multidisciplinary process. The development integrates knowledge of the underlying disease, target identification, principles on biologics safety, planning strategy for toxicology and clinical studies incorporating the key aspects of manufacturing and controls. This spring the Swedish Academy of Pharmaceutical Sciences in cooperation with SwedenBIO organizes a three-day course focusing on drug development of biologics. This course provides insights into all parts that should be addressed to effectively develop new biologics, from discovery to product launch.
The course will not only be offered as a traditional course but also as a distance course.
Who should attend?Those involved in drug development of biologics (eg in small and medium-sized companies), and need a comprehensive picture of the complex development chain.
When?May 28-30, 2018
Where?Stockholm and/or on distance
Subjects
Day 1Starting a development project/TPPTarget identificationPharmacokineticsPharmacodynamics (In vivo pharmacology)Nonclinical Safety StudiesImmunogenicityTranslational science/biomarkersPatent/IP
Day 2Regulatory strategiesManufacturing of clinical material for biopharmaceuticalsAnalysis and formulation of biologicsVirus validationManufacturing process of biologics , and medical deviceBiosimilars – preclinical and clinical aspectsAdvance Therapy Medicinal Products (ATMPs) overviewFinancing
Day 3Health economics and reimbursementClinical trialsMedical Products AgencyBusiness DevelopmentLicensing Strategies among Big PharmaPharmacovigilanceMarket, phase IV & post reg. Phase
Visit the event page for registration and further information >>