Combination Product Development: Safety/Registration/Approval
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This three-day intensive course is intended for professionals involved in safety studies for combination product development within the pharmaceutical, medical device and biotechnology industries.
The course will be especially valuable to personnel in emerging companies with limited preclinical and clinical development experience, including but not limited to:
- Managers
- Directors
- Research Scientists
- Regulatory Staff
Description
This course provides a comprehensive explanation of the preclinical development of combination products emphasizing the principles and strategies associated with the integration of toxicology studies in safety assessment of drugs, biologics and medical devices. In addition to the description of the different types of toxicity studies included in combination product development, it will also describe the relationship between pharmacology, clinical trials design, regulatory strategies and project management, aspects that are quite important to those whose function includes a requirement to include preclinical safety data into the broader perspective of product development.
Emphasis for this course is placed on the integration of toxicology studies with the overall multi-disciplinarian development of combination products that include chemical and biological interactions, impurities, manufacturing considerations and other issues that are critical to the development process. Regulatory considerations are covered along with the descriptions of the European and U.S. FDA requirements and common regulatory errors, and how these can be avoided. The goal of this course will be to give the attendee a working knowledge of combination product development, strategies for development and how to avoid the pitfalls during development.