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Purpose and Description
The CMC Focus Group provides an added benefit to pharmaceutical
scientists by providing a single, all encompassing forum to
discuss technical and regulatory CMC topics associated with the
development of pharmaceuticals. Over the past few years there
has been a lot of emphasis on modernizing the pharmaceutical
industry. The ICH/FDA/EMEA initiatives pertaining to Quality
by Design (QbD), Risk based GMPs, etc. have paved the way for
the use of risk based concepts during the development of
pharmaceuticals. Besides typical CMC challenges, the concept of
real time release has added additional technical and regulatory
challenges to the Industry. Therefore, there is an increased
need to discuss and share technical and regulatory experiences
between the various cross functional groups to ease the
implementation of these concepts in the industry. Ideally, we
are striving for discussions, an understanding, and solutions
to several issues relating to CMC that are pertinent to the
development of pharmaceuticals, biopharmaceuticals and vaccines.
Goals and Objectives
The goals of this focus group are to:
- Establish a core group of interested scientists from cross functional disciplines to discuss technical (analytical, formulation, manufacturing) regulatory, and biopharm issues pertinent to the development of pharmaceuticals, biopharmaceuticals and vaccines.
- Define and identify hot-button technical and regulatory CMC issues as they as pertinent to the development of pharmaceuticals, biopharmaceuticals and vaccines.
- Provide a forum to discuss technical and regulatory CMC issues and exchange ideas/practices.
- Identify key issues and develop plans to address issues.
- Establish sub-groups for executing aspects of the research plan.
- Examine results, establish the group to write a manuscript based on results, and discuss follow up studies.
- Facilitate workshops/symposia and thereby share experiences and communicate key lessons learned with Industry and regulators.
Membership of this group includes technical and regulatory
experts from various development areas such as small molecules,
biotech products, medical devices, consumer health care, etc.
We also anticipate active participation from agency members in
this focus group.
Upcoming Events
To be announced.
JOIN THE Chemistry, Manufacturing, and Controls FOCUS GROUP
To join the Chemistry, Manufacturing, and Controls Focus Group, click here.
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