Training courses

Training Courses, Belgrade 2010

2 ISoP training courses will be organized in Belgrade, Serbia on the 27 & 28 May 2010 :

Basic Concepts in Pharmacovigilance

Chair: Deirdre McCarthy
Basic course programme
Basic course application form

Clinical Trial Safety

Chair: Brian Edwards
Basic course programme
CTS course application form

Bursaries:

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 Belgrade training courses.
More information soon

Deadline 5 April 2010
Bursary information
Bursary application form

Venue:

Faculty of Pharmacy
University of Belgrade
450, Vojvode Stepe Street
11221 Belgrade
Republic of Serbia

Accommodation:

Please visit the website of Belgrade tourist organization http://www.tob.co.rs/eng/. It is very informative with links to hotels/hostels. It is acceptable to stay in hotel in centre and use taxi or public transport to the faculty.

Map of Serbia/Belgrade.
http://www.planplus.rs/?lang=en-us

More information can be found
Belgrade :
Belgrade, the Capital of Serbia is one of the oldest cities in Europe,  located in the south-east of Europe, in the Balkan Peninsula, at the confluence of the Sava and the Danube rivers.
http://www.serbia.travel/cms/item/grad/en/Belgrade.html
http://www.beograd.rs/cms/view.php?id=220
Serbia, general information : http://www.serbia.travel/cms/item/info/en.html
Information about travel VISA requirements for Serbia can be found at
http://www.mfa.gov.rs/Visas/VisasR.htm
When requested, ISoP will issue a letter of invitation to support a travel visa application upon registration.

If you would like more details about these courses please contact ISoP Administration.

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

Ecopharmacovigilance workshop

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
Programme (final)

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
Programme (final)

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 “ADR epidemics” 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

Two parallel training courses Pharmacogenetics and drug safety and Basic concepts in pharmacovigilance were held in Bangkok, Thailand, from 17th to 18th March, 2008 (Chaophya Park Hotel).

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

Pharmacogenetics and drug safety

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.

Pharmacogenetics and drug safety - Second Announcement (final)

Pharmacogenetics and drug safety traning course presentations

Basic concepts in Pharmacovigilance

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.

Basic concepts in Pharmacovigilance - Second Announcement (final)

Basic concept in Pharmacovigilance Traning Course presentations

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

Sevilla 2006 training course programme

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.

Barcelona 2005 training course report

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'.