LS@W Expert Classes are a series of targeted workshops organised in close collaboration with industry experts on relevant topics for Life Sciences and Medical Technologies Startups. The programme offers also 1-on-1 discussions and consultations with our mentoring Expert and Alumni to help you out, by sharing their expertise. Our Expert Classes will educate you on the specific stages of your startup.
What does it take to transform the idea for an innovative drug into a product to be used in clinical trials?
The development of a new medicine is a highly complex process and involves various disciplines. Many first-in-human studies in the EU has 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.
You are not only invited to participate – this is also your chance to ….!
Submit your case of your new medicine. You might be 1 of the 3 cases to be selected for guidance by our Experts, seasoned professionals who have over 10-30 years of experience in managing pharmaceutical discovery and development projects at Pharma companies. Deadline to submit your case: 11 October 2019. The selected cases will be discussed during the workshop of the Expert Class programme.
How to participate? and more information
- Venue: Biotech Training Facility, Sylviusweg 70, 2333 BE Leiden (click for travel directions)
- Timeframe: start 10:15 hrs – end 17:00 hrs
- Registration? Easy, send an email to Ellen de Waal | firstname.lastname@example.org.
- Who can attend? Expert classes are specially organized for Venture Challenge and Value Centre alumni, as well as for Take off participants. Startups not (yet) part of our LS@W community but who are interested in participating can join, provided you match our community profile.