Our latest release of our Industry Insights Newsletter is now available to download!
In this issue:
NEW SYSTEMS AND ICH GUIDELINES/ADDENDUM
- New EudraVigilance System
- International Conference for Harmonisation (ICH) E9(R1) Addendum
- ICH E18 Guideline on Genomic Sampling and Management of Data
- ICH E19 Guideline on Optimisation of Safety Data Collection
- Food and Drug Administration (FDA) Revises ICH Guideline M4E(R2) on Risk-Benefit Submissions
BREXIT
- EU Industry Associations Seek to Influence Brexit Negotiations
EUROPE – GUIDELINES & REFLECTION/CONCEPT PAPERS
- Revised Guideline on First-In-Human (FIH) Clinical Trials
- New Guidelines for Advanced Therapies
- Draft Reflection Paper on Designing Medicines for the Elderly, Comments by 31 January 2018
- Draft Reflection Paper on Data Extrapolation in Paediatric Medicine Development, Comments by 14 January 2018
- Draft Concept Paper on Genetic Polymorphism in Drug Metabolism (Comments Deadline now Closed)
REGULATORY INSPECTIONS
- FDA, EMA and MHRA (Medicines and Healthcare products Regulatory Agency)
USA
- New at the FDA
AND MUCH MORE!