GMP and Regulatory Expectations for Early IND Products

Overview:

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.

Why should you attend:

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.

Who Will Benefit:

• Directors
• Managers
• Supervisors
• Regulatory Affairs
• Quality Assurance
• Quality Control

Agenda

Day One

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  • Definitions and the IND that will be withdrawn.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 Two:

Lecture 1: GMPs for Phase 1 IND products

• The scope of the guidance document
• The second guidance document covering the GMPs.

Lecture 2: 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 3: Requirements for Phase 2 INDs

• The full GMPs resume, but do they?
• Phase 2 studies and the transition to full GMPs.
• CMC requirements.

Lecture 4: Preparing for IND Meetings

• Phase 1 meetings
• Pre-phase 2 meetings
• Phase 2 meetings

Price: $1,295.00 

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