Biologics Drug Development-3 day course
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 three-day 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 an online course. Those who choose to attend online will have access to all streamed lectures for 1 month. Traditional participants also have the opportunity to add lectures online. The course is organized in cooperation with SwedenBIO.
Who should attend
The course is aimed for those involved in drug development of biologics (eg in small and medium-sized companies), and need a comprehensive picture of the complex development chain. During the course you will get insight on how to work in the different stages of development, what to think about and what pitfalls there are on the road. To get the most exchange of the course, it is an advantage to have a natural science background.
Starting a development project/TPP
Pharmacodynamics (In vivo pharmacology)
Nonclinical Safety Studies
Manufacturing of clinical material for biopharmaceuticals
Analysis and formulation of biologics
Manufacturing process of biologics , and medical device
Biosimilars – preclinical and clinical aspects
Advance Therapy Medicinal Products (ATMPs) overview
Health economics and reimbursement
Medical Products Agency
Licensing Strategies among Big Pharma
Market, phase IV & post reg. phase
All lecturers have experience from drug development and most have worked with or in small drug development companies.
Day 1 ca 8:30-17:00
Day 2 ca 9:00-17:00
Day 3 ca 9:00-16:00
Olga Björklund, Xspray, Tuulikki Lindmark, Disruptive Materials, Björn Ursing, SwedenBio and Lisa Bandholtz, Apotekarsocieteten
Coming events: Events in English
i Stockholm AB
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11