What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.
These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.
A training session that will give complete understanding of these aspects
Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.
This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Advice on the GMP guidance document
At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few cases, these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.
Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.
Over these two days, Dr. Kuwahara will cover the following areas:
- Very Early Stages
- GLP requirements
- Early Pre-IND Studies
- Meetings and Preparing for the IND
- GMPs for Phase 1 IND products
- Requirements for Phase 2 INDs
- Preparing for IND Meetings.