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Latest Webinars
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Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
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Unlocking the EMA Meetings: the Process and How to Prepare Adequately
Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it…
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To Go or Not To Go Into Parallel Consultation
Are you wondering about the feasibility of parallel consultation, what sponsors should be aware of, as well as the opportunities…
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Achieve Success for Your US Product Application
The introduction of a new medicinal product to the US market follows a complex process that may extend many years…
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Advanced Therapy and Medicinal Products: How to overcome the hurdles from bench to clinic ?
We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical…
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Pitfalls and Best Practices When Conducting a Clinical Study
Since the development of the ICH GCP guidelines, clinical trials are more and more complex in a stringent regulatory framework.…
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Understand the Main CMC Challenges to Improve ATMP Development
Recent clinical successes in cell therapy and gene therapy have shown how fast this field is advancing. While the clinical…
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Opportunities for early dialogue with the EMA and HTA bodies. Optimizing product development to ensure…
Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful…
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