Biologics Drug Development-3 day course
0 kr
Preliminary program
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 also be offered as an traditional course. Those who choose to attend online will have access to all streamed lectures for 1 month.
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.
Subjects
Day 1
Biopharmaceuticals - an introduction
Starting a development project/TPP
Pharmacokinetics for biologicals
In vivo pharmacology
Nonclinical safety studies
Immunogenicity
Biosimilars – Non-Clinical and clinical aspects
Translational science/biomarkers
Day 2
Patent/IP
Regulatory strategies
Manufacturing of clinical material for biopharmaceuticals
Analysis and formulation of biologics
Safety Evaluation in manufacturing of biologics including virus validation
The Regulatory Environment in EU and US for ATMP/RMAT
Clinical Trials
Medical Products Agency
Day 3
Financing
Health economics and reimbursement
Business Development
Partnering with Big Pharma
Pharmacovigilance
Taking a project from idea to a late stage clinical development
For participants on site in Stockholm there is also plenty of networking opportunities.
All lecturers have experience from drug development and most have worked with or in small drug development companies.
Program Committe
Olga Björklund, BioArctic, Tuulikki Lindmark, TuuLife Science, SwedenBio and Lisa Bandholtz, Apotekarsocieteten
Participation fees
Please notice, you must tick a box at the registration form to indicate one of the below participation fees.
SwedenBio member, early fee until August 31, 9 500 SEK
SwedenBio member, fee from September 1, 13 000 SEK
Regular fee until August 31, 13 000 SEK
Regular fee from September 1, 16 500 SEK
All prices excludes VAT.
Preliminary schedule
Day 1 ca 08:30-17:00
Day 2 ca 08:30-17:00
Day 3 ca 08:30-17:00
Coming events: Events in English
Date | Date | Event | Days | Location |
12 nov 2024 | nov 12 | 17th Symposium on Pharmacokinetics and Drug Metabolism Mölndal | 2 | Mölndal |
18 mar 2025 | mar 18 | 2nd Nordic Conference on Computational Chemistry Göteborg | 2 | Göteborg |
Details
Biologics Drug Development-3 day course
Date: 2023-10-03
End date: 2023-10-05
No. of days: 3
Venue: Online
Town/City: Online
Other info
9500 SEK SwedenBio member online, early fee until August 31
13000 SEK SwedenBio member onlline, fee from September 1
13000 SEK Regular fee online until August 31
16500 SEK Regular fee online from September 1
All prices are excl VAT.
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043
Utbildningar
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