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 in the specific stages of your startup.
18 October 2019 | Manufacturing and control of new medicines | Leiden
- 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, 3 CMC experts will give you in-depth knowledge of CMC requirements for early development of drug products. The experts will address essential quality data and provide strategic information on CMC writing, as well as, 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.
- Stay tuned, personal invites and program to follow.
How to participate? and more information
- Registration? Easy, send an email to Ellen de Waal | email@example.com.
- 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.
- What else can you do? Tell us what your specific interest is. The programme of each Expert Class is designed to match your needs on how to be lectured and informed. Share your questions and/or issues on the topics of above-mentioned Expert Classes with us.