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3 day course in Biologics Drug Development

Monday, 28 May, 2018 - 08:30 to Wednesday, 30 May, 2018 - 16:00

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 1
Starting a development project/TPP
Target identification
Pharmacokinetics
Pharmacodynamics (In vivo pharmacology)
Nonclinical Safety Studies
Immunogenicity
Translational science/biomarkers
Patent/IP

Day 2
Regulatory strategies
Manufacturing of clinical material for biopharmaceuticals
Analysis and formulation of biologics
Virus validation
Manufacturing process of biologics , and medical device
Biosimilars – preclinical and clinical aspects
Advance Therapy Medicinal Products (ATMPs) overview
Financing

Day 3
Health economics and reimbursement
Clinical trials
Medical Products Agency
Business Development
Licensing Strategies among Big Pharma
Pharmacovigilance
Market, phase IV & post reg. Phase

Visit the event page for registration and further information >>