Links
Regulatory Authorities
Chapter I-FDA, DHHS, Part 312 IND
FDA Good Clinical Practices (GCP)
FDA Current Good Manufacturing Practice (cGMP)
DHHS, Agency for Healthcare Research and Quality (AHRQ)
European Medicines Agency (EMEA)
European Clinical Trial database
European Guides and Forms for CTA Process
Health Canada Drug Product and Application Information
International Conference on Harmonisation
Office for Human Research Protections (OHRP)
Safety, Efficacy & Coding
NCI, CTEP, Common Terminology Criteria for Adverse Events (CTCAE)
Medical Dictionary for Regulatory Activities (MedDRA)
Uppsala Monitoring Centre, WHO-DDE
EORTC, Response Evaluation Criteria In Solid Tumor (RECIST)
Professional Organizations & Trainings
American Society of Clinical Oncology (ASCO)
American Society of Hematology (ASH)
Drug Information Association (DIA)
European Organisation for Research and Treatment of Cancer (EORTC)
European Society for Medical Oncology (ESMO)
Pharmaceutical Research and Manufacturers of America (PhRMA)
Worldwide Innovative Networking (WIN) Consortium
Oncology Resources
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