Regulatory Authorities

Chapter I-FDA, DHHS, Part 312 IND

FDA Forms Distribution Page

FDA-Guidance (Drugs)

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

List of Cancers

Types of Treatment

Cancer Staging