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 attendThe 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.
LecturerAll lecturers have experience from drug development and most have worked with or in small drug development companies.
SubjectsDay 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
ProgramPreliminary 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 courseThose 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.
|Traditional participant, SwedenBIO member||8000|
|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|
Program CommitteeTuulikki Lindmark, Disruptive Materials Olga Björklund, NDA Group Björn Ursing, SwedenBio Lisa Bandholtz, Apotekarsocieteten
Venue for course on-siteThe course is held at Apotekarsocieteten, Wallingatan 26A, Stockholm
Coming events: Events in English
| 1 dec|
|Role of Analytical Chemistry in Drug Product Development – Characterization and Quality Control|
| 5 dec|
|Nordic-Baltic HTA Forum – what’s happening nationally, regionally and in EU?|
|Analysis of vaccines ONLINE meeting|
|Analysis of vaccines ON-SITE meeting|
|Regional Mass Spectrometry Imaging Spring Workshop|
Biologics Drug Development-3 day course
End date: 2018-05-30
No. of days: 3
Venue: Stockholm and/or on distance
Town/City: Stockholm and/or on distance
10500 SEK Traditional participant
10500 SEK Distance participant
8000 SEK Traditional participant, SwedenBio member
8000 SEK Distance participant, SwedenBio member
14000 SEK Traditional participant who also want to purchase the distance course
11500 SEK Traditional participant who also want to purchase the distance course, SwedenBio member
All prices are excl VAT.
i Stockholm AB
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11