Session 1: Pitfalls in Clinical Trials
The ultimate goal of clinical trials are to establish efficacy and safety of your asset. This information forms the basis for internal go/no-go decisions and ultimately provide the evidence in support of a regulatory filing and hopefully a positive benefit-risk conclusion by regulatory authorities. In order to do so clinical trials should be designed and executed in ways that allow for objective and unbiased conclusions with high external validity. Patient safety and personal integrity is of paramount importance and adherence to the principles of Good Clinical Practice (GCP) is mandatory. In order to develop drugs for a particular condition regulatory authorities have issued guidance documents for industry that set out the expectations with regard to trial design and duration, anticipated patient’s characteristics and specific endpoint of regulatory importance. Adherence to such guidelines – or previously obtained scientific advice – significantly increases the likelihood of a successful regulatory filing for marketing authorisation.
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
Developing pharmaceuticals from bench to bedside is a cumbersome and costly endeavor. Especially the clinical development but also of crucial importance in obtaining the ultimate goal of getting your product approved. Having a clear strategy for the clinical development in order to meet regulatory expectations and obtain approval of a viable indication is important. However, to meet this goal there is a need to engage with relevant regulatory authorities. These interactions may be mandatory (e.g. clinical trial applications) or it may be optional interactions that could potentially increase your likelihood of success if executed in a timely manner (e.g. scientific advice). Mapping out not only your clinical development plans and its different stages, but also planning your strategies for regulatory interactions will prepare you and your team in the best possible way. Especially if you are considering your development to target more than one jurisdiction (e.g both EU and USA) having an integrated regulatory strategy in place could enable a true global development while minimising redundancies.
This webinar will focus on clinical and regulatory strategies and exemplify how you and your team can prepare best 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.
The Presenter
Dr Steffen Thirstrup