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 course is designed for a broad range of pre-clinical,
clinical, management and regulatory personnel in
pharmaceutical, medical device and biotechnology
companies. This course is especially invaluable to personnel
in emerging companies with limited development experience
particularly in preclinical development. It also would be helpful
to scientists who have specialized in other areas of
development and desire to gain an understanding of the
safety studies involved in combination product development,
and to broaden their understanding of the regulatory
development process for drugs, medical devices and
biologics. Regulatory and managerial personnel will gain a
thorough working knowledge of preclinical development to
facilitate planning, project management and creation of
efficient development and regulatory strategies.
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.