Session 1 Pitfalls in Clinical Trials
This webinar will focus on clinical trials in general and the pros and cons of different trial designs to meet regulatory expectations. The use of regulatory guidelines including GCP and how, when and where to seek scientific advice in the absence of an appropriate guidance will be further elaborated. The webinar will be of special interest to smaller biopharmaceutical companies and academic institutions about to enter into clinical development as well as staff working in regulatory dealing with clinical development and strategy
Session 2 Importance of Clinical and Regulatory Strategies
This webinar will focus on clinical and regulatory strategies and exemplify how you and your team can prepare best possible for the time ahead. We will show how the outcome of your clinical development program will feed into your regulatory submissions such as MAA/BLA/NDA and ultimately becoming part of the publicly available information about your product. The webinar will be of interest to all who are working in clinical development or dealing with regulatory interactions with authorities.
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