CMC Certification: Staying on Top of New Developments in Gene Therapy
For CMC certified professionals, the importance of being up-to-date in your field cannot be underestimated. New drug and biologic developments occur at a rapid pace, and lack of awareness could be costly for decision-makers with compounds under development or in review.
At CfPIE, our instructors are industry professionals who have the expertise to help you tackle your real-world problems, and give insight into challenges that you may face in future. The (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™ Chemistry Certification program allows pharmaceutical professionals to not only receive CMC certification, but also dive into specialized areas and network with other professionals to increase awareness of the scope of projects currently in development.
For 2019, the FDA has released plans for CBER Guidance on Gene Therapies, drafts of which were released in July of last year. This package of guidance documents is intended to cover the development of a range of therapies, including hemophilia, retinal disorders and testing of retrovirals for autoimmune disease. Also included in the package is Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications, sure to be a topic under discussion in many of our 14 available courses in the CMC certification track.
Visit the certification review program page for more information, or call 1-610-648-7550. Don’t forget to subscribe to our mailing list to ensure that you’re in the know for new and upcoming courses with CfPIE.
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