Utbildningar

3 day course in Biologics Drug Development (previous Kurs i läkemedelsutveckling)

Free!

When you have registered as a distance course participant you will receive a booking confirmation which says that you are placed on the waiting list, please ignore that information. The information is only for participants who want to participate in the traditional course.
All practical information about the distance course will be sent approximately 3-4 weeks before the 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
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

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

Categories: Drug discovery/preclinical, Events in English, Kurs

Coming events: Events in English

Date	Date	Event	Days	Location
16 oct 2018	oct 16	2018 Joint Meeting- European DMPK meeting Göteborg	3	Göteborg	Registration
16 oct 2018	oct 16	3 day course in Drug Development Online	3	Online	Registration
16 oct 2018	oct 16	3 day course in Drug Development Stockholm	3	Stockholm	Registration
14 nov 2018	nov 14	Usability Engineering in Medical Devices Stockholm	1	Stockholm	Registration
11 dec 2018	dec 11	Software as a Medical Device – How to meet the new regulatory challenges Stockholm	2	Stockholm	Registration
5 feb 2019	feb 05	Therapeutical proteins – focus on analysis and formulations Stockholm	2	Stockholm	Registration
6 feb 2019	feb 06	Clinical Trial Agreements and other contracts – in a Nordic setting! Stockholm	1	Stockholm	Registration
5 mar 2019	mar 05	Metabolomics Mini -symposium Uppsala	2	Uppsala	Registration
7 apr 2019	apr 07	7th International Symposium on Solid Oral Dosage Form Mölndal, Gothenburg	3	Mölndal, Gothenburg	Registration