Access external website resources that focus on pharmacovigilance below.

www.healthtalk.org
Website provides free, reliable information about health issues, by sharing people's real-life experiences.

See: http://www.healthtalk.org/peoples-experiences/medical-research/clinical-trials/side-effects-and-queries
for interviews with clinical trial participants about side effects

ClinRegs online database of country-specific clinical research regulatory information

https://clinregs.niaid.nih.gov/index.php

ClinRegs, is an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research.

Countries and topics included are based on NIAID's international clinical research priorities.

 

The Global Health Regulatory Requirements Database

http://regulatory.ghtcoalition.org/

The Global Health Regulatory Requirements Database is designed to help researchers and regulatory affairs professionals access the information they need to develop effective strategies for gaining approval to conduct clinical trials and market products. The database provides high-level information on regulatory requirements, timelines, costs, and other basic information required to create product development plans for new tools.

 

The International Society of Pharmacovigilance (ISoP)

http://isoponline.org/

A professional, independent, non-profit society, open to anyone with an interest in the safe and effective use of medicinal products. ISoP considers the scope of pharmacovigilance as any area that contributes better knowledge and understanding of the safe and effective use of medicines, pre- and post-marketing, including but not limited to:

- Problems related to the active components and ingredients of medicinal products
- Problems related to medicines use
- Substandard/spurious/falsely-labelled/falsified/ counterfeit (SSFFC) medical products
- Safety problems in relation to mass medication (e.g. vaccines)
- Antimicrobial resistance and other treatment failures
- Benefit-harm assessment and risk management
- Quality issues related to manufacturing, transport or storage
- Environmental effects
- Regulatory matters pertaining to the above

The International Society for Pharmacoepidemiology (ISPE)

http://www.pharmacoepi.org/resources/guidelines_08027.cfm

A non-profit international professional membership organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, outcomes research, comparative effectiveness research, and therapeutic risk management. ISPE defines pharmacoepidemiology as the science that applies epidemiologic approaches to studying the use, effectiveness, value and safety of pharmaceuticals. ISPE publish the freely available Guidelines for Good Pharmacoepidemiology Practices (GPP).

The WHO Global Pharmacovigilance Database &
The Uppsala Monitoring Centre (UMC)

http://www.who.int/medicines/news/glob_pharmvig_database_qa/en/   &
http://www.who-umc.org/

An independent foundation and a centre for international service and scientific research improving worldwide patient safety. See UMC also for links to other WHO Collaborating Centres relating to pharmacovigilance, pharmacoepidemiology and so on

 

Drug Information Association

http://www.diaglobal.org/about-us

A global forum for all those involved in health care product development and life cycle management to exchange knowledge and collaborate in a neutral setting

 

Cochrane AE methods group

http://methods.cochrane.org/adverseeffects/

A group aiming to develop the methods for producing high quality systematic reviews and to advise Cochrane on how the validity and precision of systematic reviews can be improved. They aim to raise awareness of the adverse effects of interventions, and to promote the inclusion of adverse effects data in Cochrane reviews; to provide educational help to reviewers and users of reviews to spread and deepen understanding of the principles involved in assessing adverse effects; to provide methodological guidance on specific aspects of evaluating adverse effects; to identify areas of methodological uncertainty, and to develop a toolbox for the assessment of adverse effects.

 

The Brighton Collaboration

https://brightoncollaboration.org/public

A non-profit, scientifically independent global research network providing free standardized, validated, and objective methods for monitoring safety profiles and benefit to risk ratios of vaccines to members.

 

EMA Good Pharmacovigilance Practices

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_...

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

 

FDA Adverse Event Reporting System (FAERS)

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surve...

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.

 

MedDRA (The Medical Dictionary for Regulatory Affairs)

http://www.meddra.org/

A single standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. For use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle.

 

Uppsala Monitoring Centre tools

http://www.who-umc.org/DynPage.aspx?id=97220&mn1=7347&mn2=7252&mn3=7254

Systems and tools that may facilitate pharmacovigilance work for members of the WHO Programme for International Drug Monitoring.

 

Management of safety information from clinical trials

http://www.cioms.ch/index.php/publications/printablev3/541/view_bl/66/...

Geneva: Council for International Organizations of Medical Sciences (CIOMS) Working Group IV, 2005.

 

ABPI guidelines on phase 1 and first in human trials

http://www.abpi.org.uk/our-work/library/guidelines/Documents/guidelines_phase1_clinical_trials.pdf


Access the first in human PDF here.

 

CredibleMeds®: https://crediblemeds.org/

Is a website hosted by an independent non-profit organization that includes a list of drugs that have a risk of QT prolongation and cardiac arrhyhthmias to support the safe use of medications. A risk-stratification process includes monitoring and analysis of scientific articles in the published medical literature, information in the official drug label, reports submitted to its website and data in the FDA's Adverse Event Reporting System (AERS) using Oracle's Empirica Signal software. Drugs are placed into one of four risk categories based on their relative potential to alter the electrocardiogam (QT prolongation) and/or cause life-threatening ventricular arrhythmias.

SENSE ABOUT SCIENCE - MAKING SENSE OF DRUG SAFETY SCIENCE
University of Liverpool, Sense about Science and MRC publication - Investigating the science of side effects