This webinar is intended to provide advice on the level of detail required for regulatory submissions at different program phases. Regulatory strategy across the development program will also be discussed. For example, which items are required at each stage, which items are not required but can reduce regulatory risk both at the current stage and across the product development lifecycle.
Objectives of the Presentation:
- Regulatory strategy to increase the probability of agency accepting your submission
- How to format briefing book question in order to receive advice on path forward
- What level of detail is required in different submissions
- Prioritization of development activities
- Dealing with changes across the product development lifecycle
- Other keys to a successful submission
Why should you Attend:
To gain a better understanding of what a regulatory filing should look like, both in terms of style and content.
Regulatory filings are the key to getting into clinical studies as well as ultimately marketing your product. However, without the appropriate level of content and adequate presentation of the data, the ability to move forward in the program may be limited.
The goal of this discussion is to provide information that will help teams file successful submissions.
Senior Consultant ,
Christina Vessely, Ph.D. has over 17 years of experience in the areas of analytical and formulation development within the biotechnology industry. Her work experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. Her product experience includes insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins, as well as virus-like particles and vaccines. She has been involved in the development and execution of CMC/Regulatory strategy for both biosimilar and novel products, including fast track programs.
Her industrial experience includes the development of both liquid and lyophilized formulations for therapeutic proteins and vaccines, for both traditional and non-traditional delivery systems. In the analytical arena, Christina's areas of expertise have included method development, qualification and validation, the development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. She is experienced with various biophysical and biochemical techniques for both the routine release and extended characterization of therapeutic proteins and biotechnology products.
- Regulatory Affairs associates
- Manufacturing and analytical scientists who may be involved in writing filing sections
- Startup Companies who may be looking at submitting an IND but do not have an internal Regulatory Affairs group:
- Regulatory Affairs
- Process Chemistry
- Analytical Chemistry
- Preformulation and Formulation Development