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Latest Webinars
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…
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…
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…
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…
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.…
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…
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…
Changes and Impacts of the New EU IVD Regulatory Requirements with CDx Specifics
The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These…