10th Pharmacovigilance Conference

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10th Pharmacovigilance Conference
Date 2017-01-25
Place Radisson Blu Portman hotel, 22 Portman Square, London W1H 7BG, UK

The 10th Pharmacovigilance conference organized by Medicines for Europe[1]  is a unique event where key stakeholders gather with the aim of promoting patient safety and undertaking, to continue work towards a more efficient pharmacovigilance system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals and patient organisations. It took place on January 25th of 2017 at the Radisson Blu Portman Hotel, 22 Portman Square, London W1H 7BG, UK.

Industries provide sustainable access to high quality medicines for all European patients, for generic, biosimilar and value added medicines. Every single day, industries increase access to the best standard of care in all therapeutic areas.

Between 2005 and 2015, for the same budget, generic competition allowed twice as many patients access to medicines for key therapeutic areas such as diabetes, depression, epilepsy, cardiovascular disease, hypertension, asthma/COPD or gastro-intestinal disease.

Biosimilar medicines have also increased access to treatment with complex biological medicines. For instance, the introduction of biosimilar filgrastim, used to treat the consequences of chemotherapy, increased patient access by 44% across Europe. Not only could more patients get access to this treatment but physicians were also able to use the medicine earlier in the treatment cycle, to the benefit of the patient[2][3]</ref>

Top Photos

Top Videos

https://www.youtube.com/embed/rFoJvdc7v0U

Topics

Consists of morning sessions which reflect on achievements so far and focus on the milestones ahead and afternoon brainstorming sessions, which stimulate a lively engaging debate incorporating all perspectives[4]

Session 1: Pharmacovigilance legislation: what are the next steps? Reflections from the Commission, European Medicines Agency and the Industry.

  • Chair: June Raine, PRAC Chair, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (MHRA), UK
  • The 3-year Commission report and Impact assessment, led by the EMA - Helen Lee, DG SANTE, European Commission
  • Scanning the horizon 2017+: what are the milestones ahead of us? - Georgy Genov, Acting Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)
  • Industry’s role in patients’ safety and 2017 priorities - Wendy Huisman, Medicines for Europe PhV Working Group Chair, EU QPPV, TEVA
  • Questions and answers:
    • Social media and technology supporting patient safety: opportunities and pitfalls - David J. Lewis, Global Head of Pharmacovigilance, Novartis Pharma AG
  • Panel discussion with Phil Tregunno, Signal Management Unit Manager, Medicines & Healthcare products Regulatory Agency (MHRA), session speakers and interaction with the floor

Session 2: Enhanced EudraVigilance & Signal Detection – how to prepare for the upcoming milestones? Reflections of the regulators and the industry perspective.

  • Chair: Uwe Gudat, Head of Safety, Biosimilars, Merck Biosimilars
  • Overview of the new process for Signal Detection and Management - Georgy Genov, Acting Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)
  • EudraVigilance stakeholder change management Plan- How to prepare for the changes - Sabine Brosch, Principal Scientific Administrator, European Medicines Agency (EMA)
  • Industry Readiness for the New EudraVigilance -How can companies ensure smooth implementation? – Uwe Gudat, Head of Safety, Biosimilars, Merck Biosimilars

Session 3: Mini Workshops: how to improve pharmacovigilance activities?

  • Chair: Sabine Straus, Dutch representative of the PRAC, Head of Pharmacovigilance, Medicines Evaluation Board (MEB)
  • Educational material – is there a more efficient way to educate? - Wendy Huisman, Medicines for Europe PhV Working Group Chair, EU QPPV, TEVA
  • Medical literature monitoring – service improvements after one year implementation - John Barber, QPPV and Director, Head of Pharmacovigilance, European Operations, Dr. Reddy’s Invited: Tom Paternoster-Howe, European Medicines Agency (EMA)
  • Pharmacovigilance inspections and compliance – is there a more efficient way when companies are auditing each other? - Julia Appelskog, QPPV, Head of Pharmacovigilance, Bluefish Pharmaceuticals
  • Signal detection – what changes to implement and how? - Nicole Lang, Senior Director, PhV TA Group Leader, Biologics, Respiratory & IM, Global Patient Safety & Pharmacovigilance, TEVA
  • Topic 5: Pharmacovigilance of biologicals – implementation of GVP P.II recommendations - Michael Forstner, Managing Director, Mesama-Consulting, Switzerland

Brief summary of the workshops - Sabine Straus, Dutch representative of the PRAC, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), NL and topic leads

Chairpersons And Speakers

Adrian van den Hoven

Director General, Medicines for Europe

June Raine, Dr

PRAC Chair, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (MHRA), UK


Helen Lee

Administrator, DG SANTE European Commission

Wendy Huisman

Medicines for Europe PhV Global Head of Working Group Chair, EU, Pharmacovigilance


David J. Lewis

OPPV, Teva Systems and Data Management, Novartis

Phil Tregunno

Signal Management & Quality Standards Unit Manager, Medicines & Healthcare products Regulatory Agency (MHRA)

Georgy Genov

Acting Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)

Uwe Gudat

Head of Safety Biosimilars, Merck Biosimilars

Sabine Brosch, Mpharm, RNDr Principal Scientific Administrator, Surveillance and Epidemiology Service, Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)

Sabine Straus

Dutch Representative of the PRAC, Head of Pharmacovigilance, Medicines Evaluation Board (MEB)

Jamie Wilkinson, MSc, PGCert, MPharm (Hons), Dip HE, FRSPH

MRPharmS, Director of Professional Affairs, Pharmaceutical Group of the European Union (PGEU)

John Barber

QPPV and Director, Head of Pharmacovigilance, European Operations, Dr. Reddy's

Tom Paternoster-Howe

European Medicines Agency (EMA)

Julia Appelskog

QPPV and Head of Pharmacovigilance, Bluefish Pharmaceuticals

Joanna Harper

Expert GPVP Inspector, Medicines & Healthcare products Regulatory Agency (MHRA)

Nicole Lang

Senior Director, PhV TA Group Leader, Biologics, Respiratory & IM, Global Patient Safety & Pharmacovigilance, TEVA

Michael Forstner

Managing Director and Head Pharmacovigilance, Pharmacoepidemiology Practice, Mesama Consulting Switzerland

Barbara Claus

Hospital Pharmacist, Ghent University Hospital

Katarina Nedog

Safety & Regulatory Manager, Medicines for Europe

Top Quotes

Dr June Raine: "Massive penetration in benefit risk to proactive monitoring product life cycle helping to reach pro decision and involving HCP and patient on the safety and all of this in new era of openness and transparency."

Event Sponsors and Media Partners

  • GaBi - Generics and Biosimilars initiative
  • Generics-Bulletin.com
  • PharmaPhorum
  • PharSolution
  • QuintilesIMS [4]

References

  1. http://www.medicinesforeurope.com/
  2. http://www.medicinesforeurope.com/key-topics/#section-4<ref><ref><ref>Insert footnote text here
  3. Insert footnote text here
  4. 4.0 4.1 http://www.medicinesforeurope.com/events2017/PHV17_Programme.pdf

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