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Resources and Organizations

Our Recommendations

There are places where we go to ensure that we have the latest information and we don't mind sharing. Also, WI writers are actively involved in professional organizations that foster our continued education and the intellectual vibrancy of our industry. We've attached some links to these useful resources.

Useful Regulatory Links

International Conference on Harmonisation Guidance Documents

International Conference on Harmonisation (ICH) ICH Quality Guidance Documents ICH Safety Guidelines ICH Efficacy Guidelines ICH Multidisciplinary Guidelines

National and International Regulatory Links

NIH Clinical Trials Search (ClinicalTrials.gov) US Food and Drug Administration (FDA) US FDA Office of Orphan Products Development (FDA OOPD) European Medicines Agency Homepage (EMA) Japanese Ministry of Health, Labour, and Welfare Homepage (MHLW -- English language site) Chinese Food and Drug Administration Homepage (Chinese FDA -- English language site) World Health Organization Homepage (WHO) National Institutes of Health Homepage (NIH) NIH Medline Homepage UK Medicines and Healthcare Products Agency (MHRA) US National Library of Medicine & NIH Searchable Database (Pubmed)

Links to Recommended Organizations

American Association of Pharmaceutical Scientists (AAPS) American Medical Writers Association (AMWA) American Society of Clinical Oncologists (ASCO) Association for Research in Vision and Ophthalmology (ARVO) Diversity Alliance for Science (DA4S) Drug Information Association (DIA) European Medical Writers Association (EMWA) Healthcare Businesswomen's Association (HBA) Regulatory Affairs Professionals Society (RAPS)

Links to Patient Advocacy Organizations

American Cancer Society American Heart Association Cystic Fibrosis Foundation Therapeutic Development Network Eli Lilly Clinical Open Innovation Healtheo360 National Multiple Sclerosis Society Patients Like Me Smart Patients