Access external website resources that have relevance for pharmacovigilance below.

COUNTRY-SPECIFIC SOCIETIES/GROUPS

ISoP Chapters for Italy, Western Pacific region, Mexico, Latin America, Switzerland-Austria, Africa, South Eastern Europe, North America (NASoP), Israel, Middle East,China, Indonesia & South Asia.

ISPE Regional Chapters for Africa, Brazil, Gulf Region, Latin America & Spanish-speaking Chapter.

Society of pharmacovigilance India (SOPI)  |  Pharmaceutical information & pharmacovigilance association (PIPA), UK

American Society of Pharmacovigilance  |  Centre Anti Poison & Pharmacovigilance du Maroc, Morocco

The International Society of Pharmacovigilance (ISoP)

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)

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).

Association of the British Pharmaceutical Industry (ABPI)

Represents innovative research-based biopharmaceutical companies, large, medium and small. Publications relevant for pharmacovigilance include guidelines for the safe conduct of First in Human and Phase 1 trials, and the collection of adverse events and product complaints from market research programmes.

The Brighton Collaboration

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.

ClinRegs online database of country-specific clinical research regulatory information

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.

Clinical Trials Transformation Initiative

The mission of the CTTI is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Projects include the development of tools to improve the quality and efficiency of safety reporting for clinical trials conducted under an (United States) investigational new drug application (IND), recommendations for Data Monitoring Committees and others that may have relevance for pharmacovigilance within clinical trials and registries.

Cochrane AE methods group

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. See the website for useful recorded seminars. See also the free eBook Testing Treatments distributed via the Cochrane Collaboration.

The Council for International Organizations of Medical Sciences (CIOMS)

An international, non-governmental, non-profit organization established jointly by WHO and UNESCO that represents a substantial proportion of the biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils. CIOMS mission is to advance public health through guidance on health research including ethics, medical product development and safety. CIOMS publications have been the basis for respective ICH guidelines. Recent resources cover vaccine safety communication, active vaccine safety surveillance, evidence synthesis and meta-analysis for drug safety, management of safety infromation from clinical trials, MedDRA issues, practical approaches to risk minimisation and practical aspects of signal detection. New working groups are underway concerned with patient involvement in the development and safe use of medicines, drug-induced liver injury and clinical research in resource-limited settings. 

CredibleMeds®

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.

deprescribing.org

A Canadian initiative to share and exchange information about deprescribing approaches and deprescribing research, including useful algorithms and patient information.

Drug Information Association

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.

EMA Good Pharmacovigilance Practices

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.The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. EMA plans two more considerations chapters (Pregnancy/breastfeeding & geriatrics).

The electronic Medicines Compendium (eMC)

The eMC contains up to date, easily accessible information about medicines licensed for use in the UK. The eMC has more than 10,600 documents, all of which have been checked and approved by either the UK or European government agencies which license medicines.
Browse the site to see UK Summaries of Product Characteristics, Patient Information Leaflets, Risk Minimisation Materials (RMMs).

EQUATOR Network

Reporting guidelines for studies that include harms (e.g. extension to CONSORT, PRISMA-harms, RECORD-PE, systematic reviews including harms).

European network of centres for pharmacoepidemiology and pharmacovigilance

A network coordinated by the European Medicines Agency (EMA). The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CRO) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests are not restricted to the safety of medicines but may include the benefits and risks of medicines, disease epidemiology and drug utilisation. Participation to ENCePP is voluntary.

Checklist for study protocols 

Guide on Methodological Standards in Pharmacoepidemiology: includes the conduct of systematic reviews and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes.

Both documents are referenced in Module VIII of the good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASS) relating to authorised medicinal products, published by the European Medicines Agency (EMA).

FDA Adverse Event Reporting System (FAERS)

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. 

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

See MedWatch for useful case studies about adverse effects, product use errors, product problems and Problems with different manufacturers of the same medicine.

FDA Drug safety podcasts 

Produced by FDA's Center for Drug Evaluation and Research (CDER) and providing emerging safety information about drugs in conjunction with the release of Drug Safety Communications.

Global accelerator for paediatric formulations (GAP-f)

GAP-f fosters collaboration across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children. 

It has a useful Toolkit (and webinar) for research & development of paediatric antiretorviral drugs & formulations that includes a module on pharmacovigilance. An online version of the Toolkit is also available on the Global Health Network Training Centre.

The Global Health Regulatory Requirements Database

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.

healthtalk.org

Click Here for interviews with clinical trial participants about side effects.

Institute for safe medication practices (ISMP)

A US non-profit organisation/independent watchdog dedicated to the collaborative development, education, and advocacy of safe medication practices.

MedDRA (The Medical Dictionary for Regulatory Activities)

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.

MedSafety Scan® (MSS)

Developed by scientists at the Arizona Center for Education and Research on Therapeutics (AZCERT), asa platform for therapeutic decision support that incorporates the QTdrugs database from the CredibleMeds website with reliable drug-drug interaction predictions to identify patients at greatest risk of major adverse drug reactions.

Medication Without Harm: WHO's Third Global Patient Safety Challenge

WHO’s goal is to achieve widespread engagement and commitment of WHO Member States and professional bodies around the world to reduce the harm associated with medication. See this page for proposed solutions to address many of the obstacles the world faces today to ensure the safety of medication practices, links to relevant educational materials and real-life stories from patients, families and health care providers about how they have been affected by medication errors and harm, as well as other stories on what they have done to prevent such errors and harm from reoccuring.

Plants for Health

A global reference enabling regulators, industry, health practitioners and researchers to reliably access and exchange information concerning health products derived from plants or fungi

RxISK

A free, independent website where you can research prescription drugs and report a drug side effect - identifying problems and possible solutions when it might still be possible to intervene and find a solution.

SENSE ABOUT SCIENCE - MAKING SENSE OF DRUG SAFETY SCIENCE

An independent charity that challenges misrepresentation of science and evidence in public life, advocating openness and honesty about research, and ensuring the public interest in sound science and evidence is recognised in public debates and policymaking. This guide was produced in collaboration with the MRC-funded Centre for Drug Safety Science (a collaboration between the universities of Liverpool and Manchester). 

Sling the Mesh

This is a patient advocacy group for those injured as a result of vaginal mesh surgery. The campaign is working with ISoP to develop a global task force andspecicial interest group for medical devices.

Transcelerate BioPharma Inc

A non-profit organisation with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines. Pharmacovigilance activities aim to address challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts. A guide for risk-based monitoring (RBM) offers an adaptive approach that directs clinical trial monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. The Common Serious Adverse Events (SAE) Fields Initiative is also conducting a feasibility assessment, and develop best practices for identifying the most critical SAE fields, to increase quality of what is reported, efficiencies for sites, CROs and regulators. Transcelerate has launched open access training videos by Data Monitoring Committee experts in collaboration with the Society for Clinical Trials

The Uppsala Monitoring Centre (UMC)

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 lots of information on systems and tools that may facilitate pharmacovigilance work. See the WHO Pharmaceuticals newsletter for the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase.

WEB-RADR: Recognising Adverse Drug Reactions

Led by a consortium of world-leading experts from industry, regulatory agencies, and academia, WEB-RADR will deliver an EU-wide mobile phone app that enables users to report Adverse Drug Reactions (ADRs) directly to their National Competent Authority (NCA).

WHO Programme for Intermnational Drug Monitoring/Global Pharmacovigilance Database

The WHO Collaborating Centre for Advocacy & Training in Pharmacovigilance, based at the Centre for Tropical Clinical Pharmacology & Therapeutics, Ghana Medical School (African Collaborating Centre for Pharmacovigilance) has released a useful Pharmacovigilance Toolkit for low & middle income countries.