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 a distance 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.

Lecturer

All lecturers have experience from drug development and most have worked with or in small drug development companies.

Subjects

Day 1 Starting a development project/TPP Target identification Pharmacokinetics Pharmacodynamics (In vivo pharmacology) Nonclinical Safety Studies Immunogenicity Translational science/biomarkers Day 2 Patent/IP 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 Day 3 Financing Health economics and reimbursement Clinical trials Medical Products Agency Business Development Licensing Strategies among Big Pharma Pharmacovigilance Market, phase IV & post reg. phase

Program

Preliminary Program Preliminary schedule: day 1 ca 8:30-17:00 day 2 ca 9:00-17:00 day 3 ca 9:00-16:00

Distance course

Those who register for the online course will get access to a login link before the course starts and will have access to all streamed lectures for 1 month. Traditional participant also have the opportunity to add lectures online.

Registration Fee

 

Traditional participant	10500
Traditional participant, SwedenBIO member	8000
Distance participant	10500
Distance participant, SwedenBIO member	8000
Traditional participant who also want to purchase the distance course	14000
Traditional participant who also want to purchase the distance course, SwedenBIO member	11500

All prices are in SEK excl VAT.

Program Committee

Tuulikki Lindmark, Disruptive Materials Olga Björklund, NDA Group Björn Ursing, SwedenBio Lisa Bandholtz, Apotekarsocieteten

Venue for course on-site

The course is held at Apotekarsocieteten, Wallingatan 26A, Stockholm