GMP and Regulatory Expectations for Early IND Products 2017 is a seminar that covers topics such as:
- GLP Requirements
Toxicology and pharmacokinetics, Animal studies, A review of the guidance document and Estimating the Maximum Safe Starting Dose - Very Early Stages
The effects of ICH Q8, The need for documentation of matters that will affect downstream work, Risk analysis and design control at this stage and Impact on R & D activities - Meetings and Preparing for the IND
The CMC requirements that will be needed, Information required for the Phase 1 IND and Pre-IND Meetings with FDA - Early Pre-IND Studies
Definitions and the IND that will be withdrawn, Understanding exploratory Studies, Drugs studied under the Animal Rule, Orphan Drugs, What they are and how to conduct the studies - Requirements for Phase 2 INDs
Phase 2 studies and the transition to full GMPs, The full GMPs resume, but do they? and CMC requirements - GMPs for Phase 1 IND products
The second guidance document covering the GMPs, The scope of the guidance document, What has been omitted from the GMPs for Phase 1 and what GMPs are required at this stage - Preparing for IND Meetings
Pre-phase 2 meetings, Phase 1 meetings and Phase 2 meetings
GMP and Regulatory Expectations for Early IND Products 2017 brings together:
- Managers
- Directors
- Quality Assurance and Quality Control
- Supervisors, and lead workers in Regulatory Affairs
- Regulatory affairs workers who will need to deal with submissions covering early phase products
- Workers who will prepare GMP documents for early phase products as well as those who will review these documents