DUBLIN--(BUSINESS WIRE)--The "Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?" conference has been added to ResearchAndMarkets.com's offering.
Course "Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA. If they review your IND and the appropriate information is not available to ensure FDA of the quality of the product, the IND will be placed on clinical hold, preventing your clinical program from going forward.
The necessary content of the IND will not be discussed in this webinar, but the specific GMPs for Phase I Investigational drugs will be understood by attendees, therefore allowing the applicant to apply only those GMPs which are applicable to the drug product at this stage of development, instead of trying to apply GMPs, as defined in 21 CFR Part 211, to Phase I Investigational drug products, which often leads to frustration and even errors, as the CFR definition was meant for commercial batches, which are large and repetitive, as well as different in other ways, making the application of some of the GMPs for finished drug products impossible.
Who Should Attend:
- Quality Associates or Specialists
- Regulatory Management or Regulatory Specialists
- Compliance professionals
- Quality Auditors
- Validation Engineers
- R & D Scientists- chemists, geneticists, biochemistry specialists, formulation chemistry
- Laboratory Personnel
- Senior Quality Managers, Quality VPs
For more information about this conference visit https://www.researchandmarkets.com/research/tgsmhs/different?w=4