10th Pharmacovigilance Conference
 | |
| 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.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.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."..
Contents
About the Conference
Conference Series is organizing splendorous Pharmaceutical conferences welcomes you to attend the 12th International Conference and Exhibition on Pharmacovigilance & Drug Safety to be held during July 04-05, 2019 in Valencia, Spain. It focuses on the advancements in Pharmacovigilance, Risk Management, and Drug Safety.
The field of Pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals. 12th International Conference and Exhibition on Pharmacovigilance & Drug Safety emphasizes on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors.
Why to attend?
With members from around the world focused on learning about Pharmacovigilance and its advances; this is your best opportunity to reach the largest assemblage of participants from the Pharmacovigilance community. Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new drug developments, and receive named recognition at this 2-days event. World-Renowned Speakers, the most recent techniques, developments, and the newest updates in Pharmacovigilance are Hallmarks of this Conference.
Target Audience:
- Pharmacovigilance Students, Scientists
- Pharmacovigilance Researchers
- Pharmacovigilance Faculty
- Medical Colleges
- Pharmacovigilance Associations and Societies
- Business Entrepreneurs
- Training Institutes
- Software Developing Companies
- Manufacturing Medical Devices Companies
- Data Management Companies
Sessions/Tracks
Track 1: Pre-Clinical and Clinical Trials
Clinical trials allow the drug to be tested for safety by different ethnic population. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution. The clinical trials market has been estimated to reach USD 14.2 billion in 2016 and is projected to reach around USD 22 billion by the year 2021, and the annual growth rate of (7.5%). There are additionally numerous clinical trials started by scholarly clinical scientists. Whether started by industry or by scholastic clinical examiners and research is frequently performed in national, European and overall consortia, which can be expansive ones. Clinical research brings up moral and security issues. Clinical research is exceedingly controlled. To encourage and coordinated efforts crosswise over fringes.
Related Conferences:
Pharmacovigilance Conferences | Global Pharmacovigilance Conferences | Clinical Trials Conference | Drug Safety Conference | Clinical Case Reports Conferences | Case reports Conference | Clinical development Conferences | Drug Research Conferences | Good clinical practice Conferences | Good pharmacovigilance practices Conferences | Pharmacovigilance and Risk Management Conferences | Risk Management Conferences | Regulatory Affairs Conferences .
19th World Congress on Pharmaceutical Sciences & Innovations in Pharma Industry February 25- 26, 2019 Berlin, Germany; 4th Conference on Antibiotics Conference; June 14-15, 2019, Barcelona, Spain; 13th European Pharma Conferences May 07-09, 2019 at Frankfurt, Germany; 5th International Conference on Advanced Clinical Research and Clinical Trials, September 10-11, 2018 at Zurich, Switzerland; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 21st Annual European Pharma Congress May 20-21, 2019 Zurich, Switzerland; 4th International Conference on Drug Discovery and Advanced Drug Delivery Systems & Technologies, October 18-19, 2018 at Warsaw, Poland; 18th Annual Pharmaceutical Chemical Analysis Congress, November 05-06, 2018 at Madrid, Spain; 9th Global Experts Meeting on Neuropharmacology, November 15-16, 2018 at Frankfurt, Germany; 3rd International Conference on Generics Drugs and Biosimilars, November 15-17, 2018 at Frankfurt, Germany; Exhibition, December 02-06 2018 at Anaheim, USA; 78th Congress of Pharmacy and Pharmaceutical Sciences, September 02-06, 2018 at Glassglow, UK; 14th Nanomedicine and Pharmaceutical Nanotechnology Conferences, April 09-11, 2019, London, UK.
Related Journals:
Journal of Pharmacovigilance | International Journal of Pharmacovigilance | The International Journal of Risk & Safety in Medicine | Pharmacovigilance | Pharmacoepidemiology | Trials Journal | Clinical Research Journals | Journal of Clinical Trials | International Journal of Clinical Trials | American Journal of Clinical Trials | International Journal of Medical | Clinical Research, Journal of Pharmacology | Clinical Research | Asia Pacific Journal of Clinical Trials | Advances in Pharmacoepidemiology | Drug Safety | Drug Safety Journal | International Journal of Drug Safety | Drug Discovery | Journal of Drug Safety | Journal of Clinical Case Reports, Indian Journal of Case Reports | American Journal of Case Reports.
Related Associations or Societies:
Societies in USA: International Society of Pharmacovigilance | Drug Safety & Pharmacovigilance | Association of Clinical Research Professionals (ACRP) | American Association of Pharmaceutical Scientists | Association of British Pharmaceutical Industry | the Society of Clinical Research Associates (SOCRA) | Society for Clinical Trials (SCT) | Canadian Association of Professionals in Regulatory Affairs | Clinical Research Society (CRS)
Societies in Europe: European Association for Clinical Pharmacology (EACPT) | International Society of Pharmacovigilance (ISOP) | European Medicines Agency, Pharmaceutical Information and Pharmacovigilance Association (PIPA) | Association of CROs Czech Republic (ACRO-CZ) | European Clinical Research Infrastructures Network (ECRIN) | European Society for Clinical Investigation (ESCI).
Societies in Asia and Pacific: Society of Pharmacovigilance, International Society of Pharmacovigilance: (ISOP) | Indian Society for Clinical Organization Research (ISCR) | Indian Society for Clinical Research | Clinical Trials Society | Society for Clinical Trials Association of Clinical Research | The Society of Clinical Research Associates | Association of Clinical Research Organization | Clinical Research Society | Indian Council of Medical Research (ICMR) | Japan CRO Association (JCROA) | Pan-Asian Clinical Research Association (PACRA) | Central Society for Clinical and Translational Research (CSCTR)
Track 2: Adverse Drug Reactions
Adverse drug reactions can be considered a form of toxicity or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur during 10 to 20% of hospitalizations; about 10 to 20% of these ADRs are severe. Incidence of death due to ADRs is unknown; suggested rates of 0.5 to 0.9% may be falsely high because many of the patients included had serious and complex disorders. Incidence and severity of adverse drug reactions vary by patient characteristics (eg, age, sex, ethnicity, coexisting disorders, genetic or geographic factors) and by drug factors (eg, type of drug, administration route, treatment duration, dosage, and bioavailability). Incidence is higher with advanced age and polypharmacy.
Related Conferences:
Case Study Conferences | Pharmacovigilance and Drug Safety Meetings | Adverse Drug Reactions Conferences | Pharmacovigilance Practice Conferences | Pharmacy Practices Conferences | Risk Management and Pharmacovigilance Conferences | Challenges in Clinical Trials Conferences | Pharmacology and Pharmacovigilance Conferences | Clinical Trials and Drug Safety Conferences | Global Clinical Trials Conferences
4th Conference on Antibiotics Conference; June 14-15, 2019, Barcelona, Spain; 13th European Pharma Conferences May 07-09, 2019 at Frankfurt, Germany; 5th International Conference on Advanced Clinical Research and Clinical Trials, September 10-11, 2018 at Zurich, Switzerland; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 21st Annual European Pharma Congress May 20-21, 2019 Zurich, Switzerland; 4th International Conference on Drug Discovery and Advanced Drug Delivery Systems & Technologies, October 18-19, 2018 at Warsaw, Poland; 18th Annual Pharmaceutical Chemical Analysis Congress, November 05-06, 2018 at Madrid, Spain; 19th World Congress on Pharmaceutical Sciences & Innovations in Pharma Industry February 25- 26, 2019 Berlin, Germany; 9th Global Experts Meeting on Neuropharmacology, November 15-16, 2018 at Frankfurt, Germany; 3rd International Conference on Generics Drugs and Biosimilars, November 15-17, 2018 at Frankfurt, Germany; Exhibition, December 02-06 2018 at Anaheim, USA; 78th Congress of Pharmacy and Pharmaceutical Sciences, September 02-06, 2018 at Glasgow, UK; 14th Nanomedicine and Pharmaceutical Nanotechnology Conferences, April 09-11, 2019, London, UK.
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.[2]
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
Adrian van den Hoven was appointed Director General of Medicines for Europe on 1 September 2013. Before this he was Deputy Director General of BUSINESSEUROPE with responsibility for the International Relations and Industry departments. He worked as an International Relations researcher and adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor) prior to joining BUSINESSEUROPE in 2003. He received his doctorate in Political Science from the University of Nice, France in 2000.
June Raine, Dr:
PRAC Chair, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (MHRA), UK
Dr June Raine trained in general medicine in Oxford after completing a Masters degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority. Appointed in 1999 to head Pharmacovigilance in the Medicines Control Agency (now Medicines and Healthcare products Regulatory Agency), she was elected in 2005 to chair the CHMP's Pharmacovigilance Working Party and in 2012 as the first chair of the Pharmacovigilance Risk Assessment Committee. She is also a member of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.
Helen Lee:
Administrator, DG SANTE European Commission
Helen Lee is an administrator in the European Commission working in Unit B5 - Medicines: policy, authorisation and monitoring of Directorate General for Health and Food Safety. She joined the unit dealing with the pharmaceutical legislation and the European Medicines Agency in 2012 prior to which she had worked on food related issues in the European Commission and the UK administration.
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 [2]
References
- ↑ http://www.medicinesforeurope.com/
- ↑ 2.0 2.1 http://www.medicinesforeurope.com/events2017/PHV17_Programme.pdf
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