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18 oktober 2019, 10.15 - 17.00 hrs

Manufacturing and control of new medicines

LS@W Expert Class

  • The development of a new medicine is a highly complex process and involves various disciplines. Many first in human studies in the EU have been delayed due to lack of required information in the Investigational Medicinal Product Dossier (IMPD), which needs to be submitted to the regulatory authorities before starting a clinical trial. The IMPD describes the chemistry, manufacturing and control (CMC) of the chemical or biological drug in a clinical trial application. This quality module contains information on the drug substance (active pharmaceutical ingredient), drug product (for example an injectable, capsule or tablet product) and a placebo.
  • As a startup working on new a new drug, it is essential for you to know what the authorities expect to see in your dossier. In the upcoming LS@W Expert Class, 4 CMC experts will share their in-depth knowledge of CMC requirements for early development of drug products. The experts will address essential quality data, provide strategic information on CMC writing, and illustrate how to adhere to Good Manufacturing Practices (GMP) throughout the product life-cycle.

This is your chance to interact with seasoned professionals who have over 10-30 years of experience in managing pharmaceutical discovery and development projects at Pharma companies. Through real-life cases, you will obtain a better and useful insight what it takes to transform the idea for an innovative drug into a product to be used in clinical trials.

  • Organised in close collaboration with: LS@W Partner Progress, ProQr and LUMC.
  • Presentations: Albert Hekking & Ines Rodriguez Alvarez | Bianca Matthee | Karin Hoogendoorn.
Biotech Training Facility, Sylviusweg 70, 2333 CL Leiden
gratis
10:15 hrs Participants arrival
10:30 Start Expert Class | Welcome: Ellen de Waal, LifeSciences@Work, Science Affairs
Who’s who: including 1-minute pitches startups
11:30 Keynote: Inés Rodriguez Álvarez, Progress PME
Keynote: Albert Mekking, Progress PME
12:30 Lunch break | Checking the case posters | Collecting the question
13:15 Keynote: Bianca Matthee, ProQr Therapeutics
14:00 Keynote: Karin Hoogendoorn, Leiden University Medical Center
14:45 Workshop ‘What is your end-product?’ the road backwards based on 3 real cases, real-time!
Unique invitation to participating startup teams: Grab this opportunity to submit your case!
17:00 Wrap up & Drinks

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Biotech Training Facility
Sylviusweg 70
2333 CL Leiden

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Health Valley Partners