Training Course, Sao Paulo 2015
First announcement: ISoP training course in São Paulo, Brazil, 26-28 March 2015
ISoP in co-operation with the Brazilian national agency ANVISA and ISoP’s Latin America chapter will hold a training course on March 26th to 28th in São Paulo, one of the most important economic centres and lively cities in Brazil.
This training course is dedicated to ‘Basics in pharmacovigilance and new developments’ and will thereby address the specific needs and interests of people working on the field of pharmacovigilance either in drug agencies, pharmaceutical companies, in academia, hospitals or community settings.
Over two and half days, experts from Brazil and an international faculty will present a mixture of talks, interactive discussions and practical exercises. ISoP intends to address particularly pharmacovigilance items in the context of the Brazilian national health system and the specific situation of emerging and rapidly growing countries and health economies.
The programme will include these main topics:
- Basic concepts in pharmacovigilance
- Individual Case Harm Reports (ICHR) and reporting systems
- Establishing pharmacovigilance systems and major tasks (e.g. Risk Management Plans, Periodic Benefit Risk Evaluation Report, Qualified Person in PV)
- Pharmacovigilance and major tasks (signal detection, Post authorisation Safety Studies, CIOMS IX on effectiveness indicators)
- Special groups of drugs or treatments (vaccines, biosimilars, traditional medicines)
- Steps toward transparency and openness (access to databases, communication in pharmacovigilance, interaction with media)
ISoP by this will continue its partnership with other Latin American countries established at the 2008 Annual Meeting in Buenos Aires, at the ISoP 2012 in Cancun, the IX Encontro Internacional de Farmacovigilancia das Americas in 2012 in Brasilia, and the training course of the ISoP Latin America chapter in October 2014 as well.
Training certificates will be provided to those who complete the course.
Programme and Registration forms will be available soon from the ISoP Administration office at firstname.lastname@example.org
Rua Alvorada, 1.280 – Vila Olímpia
São Paulo SP - CEP 04550-004 - Brazil
Please follow regularly the ISoP website for further advice on the programme and registration.
Training Course, Zagreb 2014
This training course was organized in the city of Zagreb, Croatia on the 3rd & 4th April 2014, in collaboration with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED).
Proactive Pharmacovigilance, Risk Management and Pharmacovigilance in the Era of Personalised Medicine
3-4 April 2014 - Zagreb, Croatia
Coordinators: Ulrich Hagemann and Andrew Bate
At the city of Zagreb, the capital of Croatia, HALMED, the Croatian national drug agency, and ISoP welcomed 96 participants from 24 countries for its 2014 mid-year training course.
Proactive pharmacovigilance in a new environment of scientific results, medical progress, patients’ expectations and public awareness were the leading topics of the training course. Personalised medicine in this context is clearly seen as a new and challenging area for pharmacovigilantes.
For the first time ISoP included in the programme two morning sessions focusing on the medical assessment of ADRs in specific system organ classes. The presentations and discussions refreshed memories and, outlining the issues clearly, arranged the pharmacological basis of specific serious ADRs.
A couple of main items were addressed in the training course. Risk management in general, tools in epidemiology to measure effectiveness of risk minimisation activities, pharmacogenomics and the safety of drugs, and the new and strengthened role of patients in pharmacovigilance were some of these items. A separate and open session was held for the South-Eastern European ISoP chapter (SEEC) to bring together more closely ISoP members and non-members from the region.
Apart from learning and discussing, attendees enjoyed the spring-like atmosphere in the historic city of Zagreb.
Ljudevita Gaja 1
10 000 Zagreb
Hotel Dubrovnik 4* is located in the very center of Zagreb and is easily accessible from different parts of the city.
The Hotel is approximately 0.5 km from Zagreb Central Station, 1 km from the main Bus Station, and 18 km from Zagreb Airport.
Zagreb is well connected by public transport – trams and buses. The tram station at Ban Jelačić Square is only a couple of minutes walk from the Hotel. There are taxi companies in Zagreb with very reasonable prices.
We recommend the following hotels. Rooms subject to availability. The selected hotels are with WIFI access:
Hotel Dubrovnik 4*- meeting venue hotel
Other recommended hotels in Zagreb (walking distance from the venue hotel) are:
Hotel Astoria - 4 star hotel
Hotel Jadran - 3 star hotel
(Rooms subject to availability)
Capital city of the Republic of Croatia, the 28th member of the European Union, Zagreb is an old Central European city. Located in the northwest of the country, Zagreb, the largest city of the Republic of Croatia is an important crossroads between the Adriatic coast and Central Europe.
All information about Zagreb and places to visit can be found at the official Zagreb tourism bureau website or/and Croatian tourism board:
The Republic of Croatia applies the European Union’s Common Visa Policy. This means that the classic visa regime will apply to the citizens of all those countries need a visa for entering the EU member states.
Russian, Ukrainian, Turkish and Kosovo citizens, who are required a visa to enter Croatia can apply for a visa on-line at crovisa.mvep.hr. Printed and filled out application form along with other required documents should be submitted to the competent Croatian Embassy/visa centre or through an accredited tourist agency.
You can check the following link for more information
If you would like more details about this course please contact ISoP Administration
ISoP- Asia 2013 Symposium, Singapore
This 3-day symposium was held in Singapore from 19th to 21st March 2013, in collaboration with the WHO-West-Pacific Regional Office and WHO-Uppsala Monitoring Centre.
Pharmacovigilance Across Borders in Asia
Coordinators: Jean-Christophe Delumeau, Kenneth Hartigan-Go and Andrew Bate
The ISoP-Asia Symposium 2013, held from 19th to 21st of March in Singapore, was attended by 78 representatives from 22 countries.
In addition to the lectures given by ISoP Executive Committee members and representatives from the WHO-Uppsala Monitoring Centre, the symposium gave representatives from Asian Health Authorities the opportunity to present the status of the pharmacovigilance systems in their countries and to report recent achievements.
The six panel discussions interacting with the audience addressed the impact on safety monitoring taking into account the differing medical practices across South East Asian countries. The challenges faced with improving adverse reaction reporting and the country-specific factors have been addressed as well as when considering the implementation of risk minimisation methods. Interestingly, there was a clear consensus to support efforts to further harmonise safety regulatory requirements as appropriate across Asia particularly within the ASEAN area, and for upgrading national safety databases to reach E2B compatibility.
Based upon the feed-back forms completed by a majority of participants, the Symposium met, and for some even surpassed, the expectations of the audience to the extent that comments were received such as ‘the best pharmacovigilance conference organised in the region so far’.
The combination of academic and country specific presentations and the importance given to panel discussions as well was viewed positively. There is a clear demand for renewing this event in the future, and to extend the participation of pharmacovigilantes even further beyond the 22 countries that participated. This should include for example China and Japan next time. The focus should be on specific topics such as causality assessment, signal detection, audits and inspection, and risk minimisation methods suitable for Asian countries.
ISoP is committed to follow-up on this first ISoP-Asia Symposium.
click here for flyer
click here for final programme
click here for registration form (please complete and return to ISoP)
Pharmacovigilance Across Borders in Asia, ISoP-Asia 2013 Symposium, 19, 20 and 21 March 2013, TUV SUD - Singapore
|The cost for 3-day seminar (19, 20 and 21 March 2013):|
|Members of ISoP: 650 Euros
+€6 card processing fee
|Non-members of ISoP: 900 Euros
+€6 card processing fee
|Students and emerging countries, members of ISoP: 350 Euros
+€6 card processing fee
|Students and emerging countries, non-members of ISoP: 450 Euros
+€6 card processing fee
Symposium attendees in Singapore
TUV SUD PSB Ltd
1 Science Park Drive
Tel: +65 6778 7777
Fax: +65 6779 7088
We recommend the following hotel close to the venue and with easy public transport to meeting venue:
Park Avenue Rochester Hotel
31 Rochester Drive
Tel: (65) 6808 8600
Fax: (65) 6808 8633
Singapore is a city-state in Southeast Asia. Practically on the equator, Singapore is a small country on a small island with five million people. Founded as a British trading colony in 1819, since independance it has become one of the world's most prosperous countries.
All information about Singapore and places to visit can be found at the official Singapore tourism website
Training Courses, Berlin 2012
Training Courses, Berlin 2012
2 ISoP training courses in parallel were organized in Berlin, Germany on the 11th & 12th June 2012:
New EU Post-Licensing Legislation and Benefit-Risk Management
Future Perspectives for EU Pharmacovigilance
This year, ISoP conducted two parallel training courses in Berlin, Germany. It had been thought to be a good idea to have these training courses in the European Union and at that date, because the new EU pharmacovigilance legislation will become effective in July 2012. ‘New EU Post-licensing Legislation and Benefit-Risk Management’ and ‘Future perspectives for EU Pharmacovigilance’ have been the themes of the courses.
Around 50 participants from 20 different countries attended the courses, and in both courses there have been inspiring and informative talks and lively debates from the audience as well. So, ISoP is hoping having provided a forum for intense discussion on major legal changes and methodological challenges in the near future. These probably will influence pharmacovigilance practice in other regions, too.
Apart from work, attendees enjoyed the wonderful atmosphere at the meeting venue and in the vibrant city of Berlin at summer time.
Course participants and speakers in Berlin
The International Society of Pharmacovigilance can offer some financial assistance to young researchers in pharmacovigilance from emerging countries and full-time students who are members of ISoP and wish to attend the Berlin training courses.
Click here for information about bursaries
The deadline for applications has now passed.
The hotel is a four star hotel in the centre of (West) Berlin. It was opened in spring 2011 and has all facilities for small to middle size meetings.The city
Berlin, Capital city of Germany with a population of 4.29 million people.
In Berlin you will find the most important buildings of our time! Where we before could see the foundations that have given the city its image for years, you will now find new districts. Potsdamer Platz has become a city area with skyscrapers located in the heart of what in the old days was no-man's-land. From the terrace on the top floor of the skyscraper Kollhoff, you have the opportunity to enjoy a spectacular view of the DaimlerChrysler compound and the Sony complex with its particular futuristic roof.
The treasures museums of Berlin are of an amazing variety. The Pergamon altar and the Babylon gate, which you will find in the Pergamon museum on the Museum Island (Museuminsel), captivate every visitor. One of the greatest works of art of the Berlin museums is the portrait bust of Nefertiti, which you can admire in the Egyptian sections in the New Museum (Neues Museum) on the museum island.
The palaces are the most beautiful examples of the Prussian architecture: both the baroque magnificence and the classic strictness are perfectly appreciable in the numerous palaces in Berlin and its surroundings. A clear example of this is the Charlottenburg Palace (16th century). And Potsdam with its parks and palaces are famous and worth the journey (UNESCO World Heritage).
No other great city offers as many green areas as Berlin. In the city centre you will find the "Tiergarten" (17th century), the city’s green lung, which in summer is turned into a great area for festive barbecues.
More information can be found at:
Berlin Official Tourism website
If you would like more details about these courses please contact ISoP Administration (email@example.com)
Training Courses, Minsk 2011
2 ISoP training courses in parallel were organized in the city of Minsk, Belarus on the 26th & 27th May 2011, in collaboration with the Center for Examinations and Testing in Health Service of the Republic of Belarus:
Reporting, Causality Assessment, Risk factors & Mechanisms of ADRs
Reporting, Causality Assessment, Risk factors & Mechanisms of ADRs, the cost for 2-day seminar (26 and 27 May 2011):
Update Monday 16th May: Please note there is no availability for the HCP course 'Reporting, Causality assessment, Risk factors, and Mechanisms of ADRs'
Risk Management and Regulatory inspections
Risk Management and Regulatory inspections, the cost for 2-day seminar (26 and 27 May 2011)
The International Society of Pharmacovigilance (ISoP) can offer some financial assistance to young researchers in pharmacovigilance from emerging countries and full-time students who are members of ISoP and wish to attend the Minsk training courses.
Click here for information about bursaries
Venue (State Educational Institution):
Belarusian Medical Academy of Post-Graduate Education
3, Brovki str., build.3,
220013, Minsk, Republic of Belarus
We recommend the following hotels, close to the city center. Most of the selected hotels are with WIFI access. Prices include breakfast and taxes:
Hotel Victoria 4*: www.eng.hotel-victoria.by - Single room from 135 EUR
Hotel Minsk 4*: www.hotelminsk.by - Single room from 135 EUR
Hotel Belarus 3*: www.hotel-belarus.com - Single room from 95 EUR
Hotel Yubileiny 3*: www.yhotel.by - Single room from 80 EUR
Hotel Planeta 3*: www.hotelplaneta.by - Single room from 80 EUR
Republic of Belarus
The country is located in between Russia and Poland
One third of Belarus territory is covered by forests, and by beautiful lakes.
Independance from the Soviet Union since 25 August 1991, After seven decades as a constituent republic of the USSR.
Minsk, the Capital of the Republic of Belarus, is one of the most modern and unique cities of the former USSR.
Minsk is also the city where you can find the best of the Belarusian cultural heritage with museums, theatres, churches, and the world-famous Belarusian ballet.
General Information about travel VISA requirements for Belarus can be found at the Ministry of Foreign Affairs web-site address:http://www.mfa.gov.by/en/visa/
Medical insurance is required for all foreign citizens traveling to the Republic of Belarus and the insurance certificate could be asked on any border crossing or/and airport. To be eligible for emergency medical care in Belarus all foreign citizens should have the medical insurance agreement with a Belarusian insurance company or with an authorized foreign insurance company and possess the insurance certificate (policy) issued by the company. Certificate should be issued in the country of the residence. Please check with your insurance company/policy.
If your medical insurance does not cover travelling in Belarus, at the airport, before the border crossing zone, there is a Belarus insurance company department, where an insurance policy for several days could be bought for about 3 US$.
If you would like more details about these courses please contact ISoP Administration.
Training Courses, Belgrade 2010
2 ISoP training courses were organized in the historic city of Belgrade, Serbia on the 27 & 28 May 2010 in collaboration with ALIMS (Medicines and Medical Devices Agency of Serbia) and the Faculty of Pharmacy, Belgrade.
Faculty of Pharmacy, University of Belgrade
450, Vojvode Stepe Street
11221 Belgrade - Republic of Serbia
Course participants and speakers at the Faculty of Pharmacy, Belgrade
Basic Concepts in Pharmacovigilance
Chair: Deirdre McCarthy
Basic course programme
SUMMARY REPORT prepared by Ms Deirdre McCarthy
The basic course was one of the best attended ISoP courses held to date. We welcomed 80 delegates to the Faculty of Pharmacy of the University of Serbia in Belgrade for two days of instruction on the principles of pharmacovigilance, on 27 and 28 May 2010. Chaired by Deirdre McCarthy, ISoP and Viola Macolic-Sarinic, Croatian Medicines Agency, the course encompassed a day of basic concepts followed by a day of regulatory considerations. The participants availed of the opportunity to learn from a range of international and local speakers from industry, WHO, academia, and regulatory authorities.
On Day 1 we learned about the principles and mechanisms of adverse drug reactions, discussed aspects of individual case safety reports and spontaneous reporting as well as the intricacies of causality assessment. In addition, we heard about the hot topic of counterfeit medicines, signal detection from the WHO perspective and principles of risk management. The day concluded with a good panel discussion on training and education in pharmacovigilance in which we heard about a Croatian hospital e-learning program. The general consensus was that there can be no hard and fast rules on what type of person should manage and assess case reports – instead robust safety training should be the most important factor. It was also acknowledged that the skill-mix required to fully evaluate a case safety report should most probably come from a team of people, rather than one individual working in isolation.
Day 2 began with an overview of regulatory requirements for Serbia and Croatia. We then heard about ICH, CIOMS and the EU regulatory framework. An overview of medication errors from a local industry representative followed, as well as a comprehensive talk on safety considerations for the generics industry. In the afternoon, we covered PSURs, had a lively debate on vaccine-vigilance led by local and international speakers and had an introduction to pharmacoepidemiology. The day concluded with two insightful talks on preparing for EU membership by speakers from the Serbian and Croatian Agencies.
Participant feedback was very positive and the course proved to be a very valuable learning exercise in the historic and cultural city of Belgrade.
Clinical Trial Safety
Chair: Brian Edwards
Clinical Trial Safety course programme
SUMMARY REPORT prepared by Dr Brian Edwards
Around 40 people attended the first ever ISoP clinical trial safety course in the South-East European region which was co-chaired by Drs Brian Edwards (UK) and Vid Stanulovic (Serbia). The session opened with a review of the changing regulations in Croatia and Serbia given by Maja Lovrek (previously of the Croatian Agency) and Zorica Vucinic of the Medicines and Medical Devices Agency of Serbia (ALIMS). Sinisa Radulovic of the National Cancer Research Center, Belgrade then discussed further the ethical basis of clinical trials, the Declaration of Helsinki and the details of Good Clinical Practice. Herve Le Louet (Paris) described the responsibilities of an investigator with practical tips of what to do. There then followed a presentation of the importance of team-working in delivering Safety and good compliance. These team-working principles were illustrated by an exercise whereby the group broke up into six teams for a competitive exercise. Following lunch, Dr Edwards gave a summary of the responsibilities of ethics committees and competent authorities especially based on lessons learned from implementation of the EU Clinical Trial Directive. Representing the industry viewpoint, Natália Kocánková (Czech Republic) described the reporting obligations of a clinical trial sponsor. The first day ended with a discussion about the obligations of a medical monitor.
The second day started with presentation by Dr Edwards about what safety data should be collected and how followed by an update on how to assess the risk of hepatotoxicity in development given by Milena Miljkovic, Medicines and Medical Devices Agency of Serbia (ALIMS). The delegates then formed teams to assess the quality of four published clinical trials and the team leaders presented their conclusions. After lunch, Dr Edwards described the different approached to signal detection and how this is linked to managing risk in clinical trials. The second day ended with a summary of the current status of clinical trials in Oncology and HIV presented by Katarina Ilic, School of Pharmacy, Belgrade.
All in all, the discussion was lively highlighting misunderstandings about what needed to be reported and what regulatory expectations are for staff competency. This illustrates why it would be such a good idea to have a South-Eastern Europe chapter for ISoP to build on the success of this training meeting and enable networking so difficult topics can be debated thereby enhancing understanding of what we are trying to achieve through Pharmacovigilance.
Training Courses, Verona 2009
2 ISoP training courses and 1 workshop were organized in Verona, Italy on the 26 and 27 March 2009
Venue: University of Verona
chair: Giampaolo Velo
Click here for flyer
G Velo, A Wennmalm, K Olejniczak, H Lelouet, speakers of the Ecopharmacovigilance workshop
Keeping the lights green - your risk management roadmap
chair: Deirdre McCarthy
Entitled 'Your risk management roadmap - keeping the lights green' the course covered perspectives on both safety and quality risk management over two days. Twenty participants availed of the opportunity to learn from a range of international speakers from industry, WHO, academia, regulatory authorities and EMEA. We had presentations on risk management theory followed by a number of practical examples from within and outside the EU. A workshop was also held during which participants were given a proposed SmPC and background clinical and pre-clinical data on a fictitious drug. They were then asked to identify possible risks and state how best to minimize these. We also had an interactive tutorial on the future of risk management globally. During the quality risk management part of the course we heard from a regulatory authority inspector on the inspection process and the industry perspective on how to prepare for an inspection.
Participant feedback was very positive and the course proved to be a valuable learning exercise in the historic and cultural city of Verona.
Participants and facilitators of the Risk Management course, University of Verona
Basic Concepts in Pharmacovigilance
chair: Kenneth Hartigan-Go
The basic course on pharmacovigilance was well received in the lovely city of Verona with 28 participants coming from 11 countries (incl.1 bursary). Eminent speakers from the pharmacovigilance community were on hand to deliver wonderful lectures and undertake practical exercises on case studies and causality assessments. The 2 day intense course was sectioned in a logical sequence into 4 sections: basic principles, tools and methodologies, translational pharmacovigilance and risk management principles (in preparation for higher courses).
A new exciting lecture on signal pattern recognition and ADR phenomenon looking at why ï¿½ADR epidemicsï¿½ occur in the context of regulations actions, perception by health professionals and patients, industry behavior and media intervention was delivered. This is new insights and cutting edge for pharmacovigilance. Interesting topics included the medication errors and pharmacogenetics and patient safety.
The evaluation of the basic course by the participants was very good in general.
Participants and facilitators of the Basic course, University of Verona
If you would like more information about these courses please contact ISoP Administration.
Training Courses, Bangkok 2008
People who are interested in getting abstracts from these courses, please contact ISoP Administration.
With around 100 participants and a group of international speakers, these were very successful meetings. Thank you to the Thai FDA and PReMA our co-sponsors for a smooth organisation and helping us to bring together all those in the region who are interested in Pharmacovigilance.
It was also a good opportunity to promote the ISoP Western Pacific chapter.
These courses are very much in demand and this time ISoP offered 4 bursaries to young researchers from emerging countries who were able to travel and attend those courses in Bangkok.
The response from the evaluation forms was very positive, with a beautiful venue and new friendships with colleagues created, the participants were able to learn a lot from the workshops, although some of them requested more interactive activities.
Course participants and faculty at the Chaophya Park Hotel
Chair: Nicholas Moore
Attendance: 25 participants from Asia, Australia and some Europe countries
This high-level two day course was dedicated to train specialists in pharmacovigilance about a major field where pharmacogenetics is providing very relevant new insights.
The course combined lectures and discussion with very experienced Europeans and Thai teaching faculty.
Chair: Kenneth Hartigan-Go
Attendance: 67 participants from Asia, Australia and some Europe countries
This well attended two days course was dedicated to introduce non specialists to the basic concepts of pharmacovigilance and to give a neutral insight to Pharmacovigilance around the world: Mechanisms of adverse drug reactions, complexity of signal detection, causality assessment procedure, case reports, risk management, and herbal medicines were among the discussed topics.
The faculty consisted mostly of members of the ISoP Executive Committee and participants enjoyed as well the presentation from our host, Khun Wimon Suwankesawong, Head of Pharmacovigilance Unit (Thai Food and Drug Administration) about Risk Minimization tools in Thailand.
Immunopharmacology and drug safety, Budapest 2007
Training Course, 22 and 23 March 2007
Semmelweis University, Budapest - Hungary
Chair: Nicholas Moore
The programme included the following topics:
- What is immunopharmacology?
- Recent progress and ongoing developments in interfering with the immune system: boosters and inhibitors
- Direct and indirect activators and inhibitors (vaccines and monoclonal antibodies)?
- Specific risks related to immunotherapy during drug development;
- Risks identified after marketing: immuno suppression, immunostimulation.
- Specific procedures/requests for immunopharmacovigilance: setting up a risk management plan
"Immunopharmacology and drug safety" presentations are no more available our web site. ISoP Members who are interested in getting these presentations can contact ISoP Administration.
Basic concepts in Pharmacovigilance, Budapest 2007
Training Course, 22 and 23 March 2007
Semmelweis University , Budapest - Hungary
Chair : Kenneth Hartigan-Go
The programme included the following topics:
- Mechanisms of adverse drug reactions
- Individual cases: basic dataset
- working with individual and aggregate cases: causality assessment
- Spontaneous reporting: biases, benefits and limits
- Case groupings and reporting rates, identification of safety alerts and signals
- Pharmacovigilance of herbal medicines
- Risk management and the prevention of adverse drug reactions
"Basic Concepts in Pharmacovigilance" presentations are no more available our web site. ISoP members who are interested in getting these presentations can contact ISoP Administration.
Assessment and Management of Drug Liver Toxicity & Coping with Audits and Inspections, Sevilla 2006
Training Course, 2nd and 3rd February 2006
Hospital Virgen del Rocío , Sevilla- Spain
Chair: Paula Marquez
Co-chairs: Giampaolo Velo, Amer Alghabban and Corinne Pierfitte
People who are interested in getting abstracts from this course, please contact ISoP Administration.
New Challenges in Clinical Safety, Pharmacovigilance and Vaccine Vigilance, Barcelona 2005
Training Course, 10th and 11th February 2005
People who are interested in getting abstracts from this course, "New Challenges in Clinical Safety, Pharmacovigilance and Vaccine Vigilance" please contact ISoP Administration.
Decision-Making in Pharmacovigilance - Managing Risk, Berlin 2004
Training Course, 29th and 30th January 2004
People who are interested in getting abstracts from this course, 'Decision-Making in Pharmacovigilance - Managing Risk' please contact ISoP Administration
This well-attended two-day training course opposed and combined the views of industry, government and academia on the criteria, in terms of underlying data, necessary for each of the six main pharmacovigilance decisions:
1) Anticipating risks, i.e. planning post-marketing studies or surveillance on the basis of data and concerns emerging during drug development or the assessment of the application for marketing authorisation
2) Investigating risks, i.e. planning and conducting new studies if during the post-marketing phase new unresolved questions as to the safety and risk/benefit balance come up and demand urgent answers or if new techniques for the evaluation of special risks become available
3) Informing about risks, i.e. describing newly detected ADRs or interactions per quality or numerical quantity in the relevant sections of the SPC if the body of evidence reaches a certain level
4) Warning of risks, i.e. instructing patients and doctors how they can avoid or minimise those risks mentioned in the SPC
5) Eliminating risks, i.e. suspending or withdrawing the marketing authorisation of those drugs where precautionary measures including contra-indications were either not followed or not sufficient to keep the benefit/risk balance favourable
6) Communicating about risks, i.e. adequately informing patients and their doctors about how they can use a drug safely or why their drug is no longer available
Speakers stressed and discussed
a) the scientific tools necessary to provide the data for decision making, in particular large modern databases, record linkage techniques and large simple safety trials
b) the frequent inadequacy of data underlying even far-reaching actions
c) the need to plan risk-management pro-actively rather than in a merely re-active manner
d) the inter-relations of different risk-reducing measures like minimising and informing about risks as well as communicating to the public which decisions had been taken and what was the reason
e) the importance of providing well-balanced, understandable and true information in due time to consumers and their doctors.
The faculty was composed of very senior and experienced pharmacovigilance experts throughout and there was an impressive similarity in scientific thinking between regulators and company people. The forum of an ISoP Seminar proved extremely useful for in-depth and lively discussions between speakers and the audience and for 'networking' during the breaks. Participation of independent academics and a senior veterinary regulator widened the scope, and there was much appreciation that efforts will be made to compile and publish the 'take-home-messages'.