GMP and Regulatory Expectations for Early IND Products 2017

  • 13-14 Nov 2017
  • Taipei, Taiwan

Description

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    Definitions and the IND that will be withdrawn, Understanding exploratory Studies, Drugs studied under the Animal Rule, Orphan Drugs, What they are and how to conduct the studies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

Past Events

Important

Please, check "GMP and Regulatory Expectations for Early IND Products" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma

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