GMP and Regulatory Expectations for Early IND Products 2017

Key Topics

• 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  Definitions and the IND that will be withdrawn, Understanding exploratory Studies, Drugs studied under the Animal Rule, Orphan Drugs, What they are and how to conduct the studies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

Who should Attend

• 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