Which regulatory aspects are crucial to translate a new drug candidate into early clinical development?
Regulatory processes are essential for successful drug development, hence, for the approval of new medicines in order to bring a novel therapy to the patient. However, many drug developers wonder which experiments are actually required for their nonclinical package, or at which time point they should interact with regulatory agencies.
In the Online Educational Forum Lecture "Essential Regulatory Practice in the Development of Novel Therapies", Dr. Gabriele Dallmann, Consultant for approval of new medicines and co-founder of Biopharma Excellence GmbH, will help you to understand regulatory requirements as well as experimental testing of medicines for successful drug development. Dr. Dallmann is an ex-regulator who has worked at Committees of the European Medicines Agency (EMA) and at the Paul-Ehrlich-Institut (PEI) where she was in charge of the approval of antibody-containing products and has been involved in the assessment of other product classes of biopharmaceuticals including ATMPs.
The online lecture aims at answering the following questions:
- What are the important aspects for the nonclinical package for early stage developments?
- From a regulatory perspective, what are the principally required data to translate a new drug candidate into early clinical development?
- What needs to be taken into account for the design of the FIH study?
- How do CMC packages differ from early to late stage developments?
- How and when to interact with regulatory agencies?
We currently offer two public Lecture Series, which alternate each month:
The SPARK-BIH Educational Forum is designed to teach academic scholars the principles of Drug, Device & Diagnostic Development with focus on topics which are relevant for translational medicine.
In our SPARK-BIH Entrepreneurial Forum we recruit key opinion leaders in the fields of Business Planning & Development, Financing and Commercialization to teach entrepreneurial scientists.
SPARK-BIH is a mentoring program that supports academic inventions with education, mentorship and funding. The program is designed to de-risk projects with high potential impact, addressing critical unmet medical needs for any medical indication. Our aim is to accelerate the translation of academic inventions into outstanding medical products including novel drugs, repurposing drugs, advanced therapy medicinal products, such as cell and gene therapies, diagnostics and medical devices.