GMP and Regulatory Expectations for Early IND Products at San Diego
Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products.
Online, March 1, 2012 (Newswire.com) - Overview: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products.
Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified 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 the pharmaceutical worker should be aware of this. This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.
Areas Covered in the Session:
Day 1, April 5, 2012
Lecture 1: Very Early Stages
The need for documentation of matters that will affect downstream work.
The effects of ICH Q8
Impact on R & D activities
Risk analysis and design control at this stage.
Lecture 2: GLP Requirements
Animal studies
Toxicology and pharmacokinetics.
Estimating the Maximum Safe Starting Dose
A review of the guidance document.
Lecture 3: Early Pre-IND Studies
Understanding exploratory Studies
Definitions and the IND that will be withdrawn.
Orphan Drugs
Drugs studied under the Animal Rule
What they are and how to conduct the studies.
Lecture 4: Meetings and Preparing for the IND
Information required for the Phase 1 IND
The CMC requirements that will be needed.
Pre-IND Meetings with FDA
Day 2, April 6, 2012
Lecture 5: GMPs for Phase 1 IND products
The scope of the guidance document
The second guidance document covering the GMPs.
Lecture 6: GMPs for Phase 1 continued
A presentation covering what GMPs are required at this stage.
What has been omitted from the GMPs for Phase 1.
Lecture 7: Requirements for Phase 2 INDs
The full GMPs resume, but do they?
Phase 2 studies and the transition to full GMPs.
CMC requirements.
Lecture 8: Preparing for IND Meetings
Phase 1 meetings
Pre-phase 2 meetings
Phase 2 meetings
Who will benefit:
Directors
Managers
Supervisors, and lead workers in Regulatory Affairs
Quality Assurance and Quality Control
Workers who will prepare GMP documents for early phase products as well as those who will review these documents
Regulatory affairs workers who will need to deal with submissions covering early phase products.
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