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Pharmacovigilance Resources

Pharmacovigilance Resources

RARE EVENTS: The Inside Story of a Worldwide Quest for Safer Medicines

*Ralph Edwards: RARE EVENTS: The Inside Story of a Worldwide Quest for Safer Medicines  SpringerLink

Please read Dr. Ulrich Hagemann’s book review on ‘Ralph Edwards RARE EVENTS’ here.

Manual de Buenas Prácticas de Farmacovigilancia
A new ebook ‘Manual de Buenas Prácticas de Farmacovigilancia’ edited by Rosa María Papale, Santiago Schiaffino and Maria Guadalupe Garcia Darderes (in Spanish). Click HERE
(October 2018)
The role and strategy of ISoP in global pharmacovigilance
The role and strategy of ISoP in global pharmacovigilance
Article published in International Journal of Clinical Pharmacy
(July 2018)
ISoP Monograph
ISoP Monograph “Pharmacovigilance – Critique and ways forward”
Editors: I. Ralph Edwards and Marie Lindquist
Women's Medicines Group
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
ENCePP is pleased to announce that Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology is now available.

In addition to the revision or update of most chapters, it includes a new chapter on ‘Design and analysis of pharmacogenetic studies’, written in collaboration with the Special Interest Group in Molecular Epidemiology, Biomarkers and Pharmacogenetics of the International Society of Pharmacoepidemiology (ISPE).

Related information, please click here
(14 July 2014)

The Clinical Trials Regulation was published on 27 May 2014 in the Official Journal of the European Union (EU).
The new legislation will not come into force until the necessary IT platforms to support the exchange of information are in place (see Articles 80 and 81). This is anticipated as being no earlier than mid-2016.

For more information please see the EMA website


The European Medicines Agency (EMA) would like to inform you that the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group on 3 May 2011.

The document is now available on the following link:

The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been subject to a public consultation. An overview of comments received and how each was addressed will also be available on the ENCePP website (
This guide is an important tool that reviews and gives direct electronic access to methodological guidance for research in pharmacoepidemiology and pharmacovigilance. It is planned that updates of the electronic document will be performed regularly with a view to maintaining the dynamic nature of the guide.

New UMC book 'Expecting the Worst'
Erice Statement 2009
Erice Statement 2009: Communication, Medicines and Patient Safety
Download here

Re-use of this article is permitted in accordance with the Terms and Conditions set out at

Announcements FDA
There are several automatic email subscriptions that will provide you information from FDA to consumers, healthcare professionals and industry. Here are links to several email subscription services located on , that ISoP membership can subscribe to :

Health Professional Updates scroll to the bottom for links to:

MHRA - Targeted Research Programme
Official launch of the Targeted Research Programme held on 6 November 2009, London
WHO Drug Information
European Medicines Agency (EMA)
An interesting publication of the European Medicines Agency (EMA) :
“Connecting the dots. Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives”

(As at January 2016)

EMA consultation: Draft guideline on good pharmacovigilance practices (GVP) 3 – Module V – Risk management systems (Rev 2) and  Draft guidance on format of the risk management plan (RMP) in the EU (Posted 07/03/16)

The European Medicines Agency has released for public consultation a draft guideline on good pharmacovigilance practices (GVP) 3 – Module V – Risk management systems (Rev 2) and a draft guidance on format of the risk management plan (RMP) in the EU – in integrated format.
Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This draft guideline on good pharmacovigilance practices (GVP) 3 – Module V – Risk management systems (Rev 2) is the first major revision clarifyings the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.

The document open for consultation is available by clicking here

The European Medicines Agency is consulting stakeholders, through the draft guidance on format of the risk management plan (RMP) in the EU – in integrated format, on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focused risk management system and simplifying the way information is submitted to the regulators.

The document open for consultation is available by clicking here

Please note that the deadlines for comments for both documents is Tuesday 31 May 2016.


EMA consultation: Draft scientific guidance on post-authorisation efficacy studies (Posted 11 Nov 2015)

The European Medicines Agency has released for public consultation a draft scientific guideline on post-authorisation efficacy studies.

Post-authorisation efficacy studies (PAES) of medicinal products are studies conducted within the authorised therapeutic indication to complement available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that should be, or can only be, addressed post-authorisation.

This guidance is intended to provide scientific guidance for marketing-authorisation holders and national competent authorities on post-authorisation efficacy studies with regard to methodological considerations and the potential role of particular study designs. This guidance does not include procedural aspects, which are dealt with in the human post-marketing authorisation regulatory and procedural guidance.

This guidance has been developed in accordance with Article 108a of Directive 2001/83/EC which provides a mandate for European Medicines Agency (EMA) in cooperation with competent authorities and other interested parties to draw up scientific guidance on PAES.

The document open for consultation is available by clicking here


EMA Communication: The European Medicines Agency has released a draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products. The document open for consultation is available by clicking here. Deadline for comments for this draft guideline was 30 July 2014


EMA Communication: Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations

EU Regulatory workshop on Medication Errors – 28 February and 1 March 2013 – Meeting report published

The meeting report of the Medication errors workshop held at the EMA on 28 February – 1 March 2013 has now been published on the EMA website.

EU Pharmacovigilance Regulation updates

The pharmacovigilance Regulation (EU) 1235/2010 amending Regulations (EC) 726/2004 and (EC) 1394/2007 was published in the Official Journal of the European Union on 31/Dec/2010

It is not due to come into force until 02/Jul/2012.

The corresponding Pharmacovigilance Directive 2010/84/EU amending Directive 2001/83/EC was published in the same edition of the Official Journal of the European Union

This Directive enters into force on the 20th day following its publication in the Official Journal of the European Union (i.e. Sunday 20/Jan/2011), but Member States have until 21/Jul/2012 to adopt its provisions.

European Medicines Agency Consultation: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

The European Medicines Agency has recently published a draft “Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues”.

The current quality guideline (EMEA/CHMP/BWP/49348/2005) was published in 2006, at a time where little experience was available on the registration of biological medicinal product claiming to be similar to another one already marketed. Significant experience has now been gained and it is recognised that the guideline needs refinements taking into account several practical considerations relating to the lifecycle (from development to product discontinuation) of similar biological medicinal products.

The Concept paper is available on the following webpage:


European Medicines Agency’s Press Release: Review of the manufacture of Baxter’s peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches

Following our previous communication regarding the presence of endotoxins in peritoneal dialysis (PD) solutions produced by Baxter (Dianeal, Extraneal and Nutrineal), we would like to inform you that the problem has not been solved and that Baxter cannot guarantee the production of endotoxin-free solutions from a production line at its Castlebar plant in Ireland in the short-term. As a consequence, the Agency’s Committee for Medicinal Products for Human Use (CHMP), at the request of the European Commission, started a full review of the manufacture of Baxter’s dialysis solutions at the affected plant. There is a risk that patients who receive PD solutions that contain endotoxins may develop aseptic peritonitis. However the number of PD bags affected is likely to be very small and the overall risk to patients remains low.

Patients and healthcare professionals should continue to look out for any symptoms that suggest the development of aseptic peritonitis (e.g. cloudy effluent seen in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and possibly fever) and report any cases as soon as possible. Once finalised, the Agency will communicate the outcome of the CHMP’s review. Healthcare professionals will be sent updated advice, including information on new supplies from outside the EU as it becomes available. The EU regulatory system is intensively monitoring this issue on a continuous basis.

The complete press release document referring to this matter can be found in the following link:


European Medicines Agency’s Road map to 2015

The European Medicines Agency has published its final ‘Road map to 2015’ today, coinciding with the 16th anniversary of its inauguration. You can find it in the link below:

The ‘Road map to 2015’ sets out the Agency’s vision in further developing its role as a European public-health agency in the field of medicines and has been drafted in consultation with the Agency’s partners and stakeholders to ensure as broad a consensus as possible on the best way forward.

The road map proposes three priority areas for future actions to strengthen the Agency’s role in protecting and promoting human and animal health in the European Union:

  • Addressing public-health needs by: stimulating medicines development in areas of unmet medical needs, neglected diseases and rare diseases, and for all types of medicines for veterinary use; facilitating new approaches to medicines development; applying a more proactive approach to public-health threats where medicines are implicated.
  • Facilitating access to medicines by: addressing the high attrition rate during the medicines-development process; reinforcing the benefit/risk-balance assessment model; continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review.
  • Optimising the safe and rational use of medicines by: strengthening the evidence base in the post-authorisation phase to enable better regulatory decision-making; enhancing patient safety by avoiding unnecessary risks to patients as a result of the use of medicines; becoming a reference point for information on medicines evaluated by the Agency; improving the decision-making process by taking due account of patient experience, thus contributing to the rational use of medicines.

In developing its road map, the Agency continues to ensure that its vision is consistent with and complementary to strategic directions provided by the European Commission, the Council of the European Union and the Heads of Medicines Agencies. Detailed information on the implementation of the road map will be provided in the document ‘From vision to reality’, to be published shortly.


EMA Human Medicines Highlights

This newsletter is addressed to patients, consumers and healthcare professionals’ organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency.

The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intended to comprise a full set of the Agency’s information.

Good Pharmacovigilance Practice Guide
Book description & purchasing: Pharmaceutical Press (official publisher).
Also available at Amazon.
EudraVigilance Expert Working Group's (EV-EWG's)
The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day to day pharmacovigilance activities of stakeholders in the EU. The IME list is intended for guidance purposes only.
The Observational Medical Outcomes Partnership
The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership designed to protect human health by improving the monitoring of drugs for safety and effectiveness. The partnership will conduct a two-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate safety issues of drugs already on the market. OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration (FDA), and other federal agencies. It is funded and managed through the Foundation for the National Institutes of Health.

OMOP plans to use its website as a primary tool to engage with the broader research community throughout the initiative. The research team will post research proposals for public review and comment, facilitate discussion forums around specific methodological issues of observational analyses, and share learnings from all research conducted. We will also use the site to post job openings and requests for application for specific research tasks to allow interested parties to get involved themselves. If you are interested in reviewing OMOP proposals and participating in forum discussions, simply create a new account and log in and you will have access to all the posted documents. You will also be able to register for RSS feeds to let you know when material has been updated.

OMOP website

Erice Manifesto 2006
In June 2006, in Erice (Sicily) a group of twenty-seven experts in pharmacovigilance discussed and debated the global reform of the safety of medicines for patients (The Erice Manifesto is published in Drug Safety journal).

Special Article: The Erice Manifesto

London Declaration

London, United Kingdom, 8 February 2006 Today, patient and consumer organizations joined together to welcome the publication of the London Declaration from Patients for Patient Safety following the World Health Organization’s (WHO) first Patients for Patient Safety workshop last year. The International Alliance of Patients’ Organizations (IAPO) and Consumers Advancing Patient Safety (CAPS) commended the WHO on incorporating the patients’ voice in a meaningful way into the WHO World Alliance for Patient Safety and congratulated Patients for Patient Safety on its achievements to date. Patients for Patient Safety is one of six action areas of the WHO World Alliance for Patient Safety.

“Patients must be at the centre of our quest to improve patient safety” said Sir Liam Donaldson, Chair of the World Alliance for Patient Safety. “When things go wrong, they and their families suffer from any harm caused. Patients for Patient Safety is designed to ensure that patients and their families are a central part of international efforts to improve patient safety through this WHO Alliance”.

The groundbreaking Patients for Patient Safety workshop was held in London, 27-30 November 2005 running in parallel to the EU Summit on Patient Safety, organized by the UK Government in its role of Presidency of the EU during 2005. Following a competitive application process, 24 patient and consumer advocates – patient safety champions – were selected together representing 21 countries across developed, transitional and developing countries, providing a truly global voice.

The key outcome of the workshop was the publication of the London Declaration through which the patient safety champions expressed their vision for safer health care systems worldwide and highlighted concrete areas where patients and consumers – and the organizations that represent them – can work in partnership with health providers to make a significant contribution to the improvement of patient safety.

“We learned from the 24 thoughtful patient safety champions that challenges in delivering safe, compassionate health care cut across all geographic, ethnic and socio-economic boundaries”, said Susan E. Sheridan, MIM, MBA, CAPS Co-Founder and President and Lead of Patients for Patient Safety. “The London Declaration will be the soul of the work of the World Alliance”.

IAPO and CAPS congratulated the workshop participants for their incredible focus and skill in defining and developing the role of patients and consumers in the WHO’s World Alliance for Patient Safety. In addition to the concrete outcomes, the workshop was also an important signal of highlighted the importance of the patient voice in health policy-making.

IAPO and CAPS have announced their support for the London Declaration with its commitment to harness the expertise, knowledge and motivation of consumers and patients to work through partnerships to improve patient safety for all patients. IAPO Chair, Albert van der Zeijden, commented, “This Declaration demonstrates the strong commitment of consumers and patients, and the organizations that represent them, to contribute their knowledge and expertise to improve patient safety in a structured and effective way”.

Note to Editors:

1. CAPS is a consumer-led non-profit organization formed to be a collective voice for individuals, families and healers who wish to prevent harm in healthcare encounters through partnership and collaboration. CAPS envisions a partnership between consumers and providers to create global healthcare systems that are safe, compassionate and just. Susan E. Sheridan, MIM, MBA, CAPS Co-founder and President, also leads Patients for Patient Safety, the consumer action area of the WHO World Alliance.

2. IAPO is the only global alliance representing patients of all nationalities across all disease areas and promoting patient-centred healthcare worldwide. Our members are patients’ organizations working at the local, national, regional and international levels to represent and support patients, their families and carers. A patient is a person with any chronic disease, illness, syndrome, impairment or disability. IAPO was founded in 1999 by forty patients’ organizations from around the world.

3. Patients for Patient Safety is one of the six action areas of the World Alliance for Patient Safety and is designed to ensure that the perspective of patients and families, consumers and citizens – whichever term resonates best – in both developed and developing countries is a central reference point in shaping the important work of the Alliance.

4. The patient champions selected were from 21 countries: Argentina; Australia; Canada; China; Egypt; Fiji; Germany; India; Italy; Mexico; The Netherlands; Nigeria; Pakistan; Poland; Sudan; Uganda; Ukraine; United Kingdom; United States of America; Yemen and Zambia.

5. The London Declaration is available online here.

For further information, please contact:

Mr Mitchell Dvorak
Executive Director
Consumers Advancing Patient Safety (CAPS)
Tel: (312) 274-1301
Fax: (312) 274-9696

Ms Jo Harkness
Policy & External Affairs Director
International Alliance of Patients’ Organizations (IAPO)
Tel: +44 20 7721 7597
Fax: +44 20 7721 7596
Website: .

BMA report about pharmacovigilance
Report: pdf file
Guidelines on ADRs

Drug Safety, ISoP official journal

Drug Safety is the premier international journal covering the disciplines of pharmacovigilance, pharmacoepidemiology, benefit-risk assessment and risk management.

Drug Safety’s structured program of peer-reviewed invited articles ensure comprehensive and critical coverage of all topics. The journal specializes in definitive reviews on the epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.

Benefit-risk assessments provide an in-depth review of adverse effect and efficacy data for a drug in a defined therapeutic area. High-quality original research focusing on the clinical implications of drug treatment safety issues is also published.
Drug Safety is published by Springer.

Discounted Drug Safety subscription

Drug Safety journal is available on Members Section (for ISoP members only)

Guidelines for publication of adverse drug reaction reports in Drug Safety

Recommendations of a joint ISoP-ISPE group on the guidelines for the submission and publication of adverse drug reaction reports. This paper is published simultaneously in Drug Safety, ISoP’s official journal, and in Pharmacoepidemiology and drug safety, ISPE’s journal.

If ever you submit an adverse drug reaction report to a journal, please respect these recommendations, and cite this paper:

Click here for the Guidelines for publication of Adverse Drug Reaction reports

The content of this paper represent’s ISoP position, and not only its authors’.

European Medicines Agency. Good pharmacovigilance practices (GVP Modules I to XVI)