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Pharmacovigilance In-house Training

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

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Course overview

This comprehensive three-day pharmacovigilance training course has been designed to provide an introductory guide for all those concerned with vigilance industry. The interactive programme will cover topics from basic pharmacovigilance principles and terminologies through to the current regulatory framework and its global impact, including drug surveillance in the EU, US and Japan. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments and effective signal detection.

Our panel of experts will offer practical guidance throughout the training course and use real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance your understanding of pharmacovigilance issues.

Key topics to be addressed include:

  • Principles of pharmacovigilance and data resources
  • Risk management, causality assessment and postauthorisation safety and efficacy studies (PASS/PAES)
  • Pharmacoepidemiological studies and evolution of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and development safety update reports (DSURs)
  • Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment
  • Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe
  • Drug surveillance in countries outside Europe
  • Post-marketing surveillance: observational cohort studies
  • An overview of signal detection and risk management plans (RMPs)

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Who should attend?

Anybody involved and interested in the daily practice of pharmacovigilance, including pharmaceutical physicians and those working in:

  • Drug safety
  • Adverse reaction monitoring
  • R&D
  • Regulatory affairs
  • Registration

United Kingdom

  • .
  • 2Health Limited
  • Actavis plc
  • Actelion Pharmaceuticals
  • ADAMAS Consulting
  • Adamas Consulting Ltd
  • Alcon Laboratories (UK) Ltd
  • Allergan UK Limited
  • Antisoma Research Ltd
  • Arrow No.7 Limited
  • Aspar Pharmaceuticals Ltd
  • AstraZeneca
  • AstraZeneca R&D Charnwood
  • AstraZeneca UK Ltd
  • Auden McKenzie Group
  • Avecia Biotechnology Ltd
  • Bell's Healthcare
  • Bells Healthcare
  • Biogen IDEC Ltd
  • British American Tobacco Ltd
  • Brown & Burk UK Ltd
  • BTG International Ltd
  • Cambridge Healthcare Supplies Ltd
  • Celgene Europe Ltd
  • Cephalon (UK) Limited
  • Cephalon UK Ltd
  • Chiesi Limited
  • Chiesi Ltd
  • Chiltern International
  • Chugai Pharma Europe Ltd
  • City University, London
  • Clinigen
  • Cmed Clinical Research Services Ltd
  • Cycle Pharmaceuticals
  • DAIICHI PHARMACEUTICALS UK LTD
  • Daiichi Sankyo UK Ltd
  • Dannika Consulting Ltd
  • Department of Health
  • Diamond Pharma Services
  • DR REDDYS LABORATORIES (UK) LTD
  • Eisai Europe Limited
  • Eisai Limited
  • Eisai Ltd
  • Eli Lilly & Co Ltd
  • Eli Lilly & Company Limited/Elanco Animal Health
  • Emas Pharma Ltd
  • Epic Database Research Company Ltd
  • European Medicines Agency
  • EUSA Pharma
  • Ewopharma International s.r.o.
  • Ferring Pharmaceuticals Ltd
  • Genus Pharmaceuticals Ltd
  • GlaxoSmithKline
  • GlaxoSmithKline Services Unlimited
  • GMClinical
  • GW Pharmaceuticals
  • GW Pharmaceuticals Limited
  • GW Pharmaceuticals Ltd
  • Harefield Pharmacovigilance Ltd
  • Hospira UK Limited
  • Hospira UK Ltd
  • Idis Limited
  • Immunocore Limited
  • Immunocore Ltd
  • IMS HEALTH LTD
  • IMS Health UK
  • INVERNESS MEDICAL INNOVATIONS LTD
  • Ipsen Biopharm Ltd
  • Janssen-Cilag Ltd
  • Jazz Pharmaceuticals
  • JensonR+ Limited
  • Kyowa Kirin
  • Kyowa Kirin International
  • M&A Pharmachem
  • Marlborough Pharmaceuticals Ltd
  • Martindale Pharma
  • Meda Pharma Ltd
  • Meda Pharmaceuticals Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medtronic Ltd
  • Merck Pharmaceuticals Limited
  • Merck Sharp & Dohme Ltd
  • Mitsubishi Tanabe Pharma Europe
  • Mundi Pharma Int Ltd
  • Mundipharma Research Ltd
  • Mundipharma Research Ltd.
  • NDA Regulatory Science Ltd
  • Nelsons
  • Nicoventures Ltd
  • Norgine Ltd
  • Novartis Pharmaceuticals UK Ltd
  • Novatis Animal Health UK Ltd
  • Novo Nordisk Ltd
  • Octapharma Ltd
  • OMNICARE CLINICAL RESEARCH LTD
  • Oracle Corporation UK Ltd
  • Oxford Biomedica
  • PAGB (The Proprietary Association of Great Britain)
  • PAION UK Ltd
  • Parexel International Ltd
  • Perkin Elmer LAS (UK) Ltd
  • Piramal Healthcare Ltd
  • Procter & Gamble
  • Procter & Gamble Technical Centres Ltd
  • Procter and Gamble Technical Centres Ltd
  • ProductLife Group
  • ProductLife Limited
  • Profile Pharma
  • Public Health England
  • Pure Drug Safety Ltd
  • QA Pharmaceutical Services
  • RANBAXY EUROPE LTD
  • Reckitt Benckiser
  • RECORDATI PHARMACEUTICALS LTD
  • Regional QC Laboratory
  • Roche Products Ltd
  • Rosemont Pharmaceuticals
  • Rosemont Pharmaceuticals Limited
  • Rosemont Pharmaceuticals Ltd
  • Rosemount Pharmaceutical
  • Rotapharm Ltd
  • SCHERING HEALTH CARE LTD
  • SCHWARZ PHARMA LTD
  • Scottish National Blood Transfusion Service
  • SEQ Limited
  • Servier R&D Ltd
  • Shire Pharmaceutical Ltd
  • South Devon Healthcare NHSTrust
  • SPMSD
  • Stiefel Laboratories
  • Stiefel Labs (UK) Limited
  • Strakan Pharmaceuticals, Prostrakan Limited
  • Sunovion Pharmaceuticals Europe Ltd
  • Swedish Orphan Biovitrum
  • Takeda Development Centre Europe Ltd
  • Takeda UK Limited
  • Teva UK Limited
  • The Mentholatum Company
  • Thornton & Ross Ltd
  • Toray Industries Inc
  • Torbay and South Devon NHS Trust
  • Trac Services Ltd
  • UCB Celltech
  • UCB Pharma Limited
  • Unilever
  • United Therapeutics Europe Ltd
  • University of Bradford
  • University of London
  • Veriton Pharma
  • Warner Chilcott Pharmaceuticals UK Ltd
  • WBA Global Sourcing
  • Weleda
  • Winthrop Pharmaceuticals UK Ltd
  • Wise Pharmacies Limited
  • Wockhardt UK Limited
  • Wyeth Europa Ltd
  • Wyeth Pharmaceuticals
  • Zanza Laboratories Ltd

Switzerland

  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd
  • Actelion Pharmaceuticals Ltd.
  • F. Hoffmann La Roche
  • F. Hoffmann-La Roche
  • F. Hoffmann-La Roche Ltd
  • Geistlich Pharma
  • Ginsana SA
  • Helsinn Healthcare S.A.
  • IBSA Institut Biochimique SA
  • Nestle Research Centre
  • NNIT A/S
  • Novartis Consumer Health SA
  • Novartis International AG
  • Novartis Pharma AG
  • Roche
  • Roche Pharma (Schweiz) AG
  • Roche Pharma (Switzerland) Ltd
  • SkyePharma AG
  • Speedel
  • SWISS REINSURANCE COMPANY
  • Swiss Tropical Institute
  • United Biosource Corporation
  • Universitätsspital Basel/ Department Klinische Forschung
  • Vifor SA

Germany

  • ABBOTT GmbH & Co KG
  • Abbott Laboratories GmbH
  • Abbott Products GmbH
  • Bavarian Nordic GmbH
  • Bayer AG
  • Bayer Pharma AG
  • Centre for epidemiology and health research (ZEG)
  • Dr Willmar Schwabe GmbH & Co
  • Fresenius Kabi Deutschland GmbH
  • Life Molecular Imaging
  • Linde
  • Medac GmbH
  • Merck KGaA
  • Mundipharma Research GmbH & Co Kg
  • Mylan Healthcare GmbH
  • Otsuka Pharmaceutical Development and Commercialisation Europe
  • Solvay Deutschland GmbH
  • Takeda GmbH

Netherlands

  • Abbott Healthcare Products B.V
  • Apotheekzorg
  • ApotheekZorg Sittard
  • Astellas BV
  • Astellas Pharma Europe BV
  • Aurobindo Pharma BV
  • Bilthoven Biologicals BV
  • Celgene B.V
  • Centrafarm Pharmaceuticals BV
  • DADA Consultancy BV
  • Genzyme Europe BV
  • HAL Allergy BV Leiden
  • Julius Clinical Research
  • Leyden Delta bv
  • Merck BV
  • Merck Sharp & Dohme
  • N.V. Organon
  • Synthon Biopharmaceuticals BV

Belgium

  • 4 Clinics
  • Baxter R&D Europe
  • Bristol-Myers Squibb SA
  • Colgate Palmolive Research & Development Inc
  • Colgate-Palmolive R&D
  • Glaxo Smithkline Biologicals
  • GlaxoSmithKline
  • GlaxoSmithKline Vaccines
  • Guerbet
  • Janssen Pharmaceutica NV
  • Oystershell NV
  • Sanofi-Aventis
  • SGS Belgium NV
  • SGS Belgium NV Life Science Services
  • UCB Pharma SA

France

  • Aeras Global TB Vaccine Foundation
  • Air Liquide Santé International
  • AnticipSante SAS
  • DBV Technologies
  • Guerbet
  • Johnson & Johnson
  • Lallemand
  • LFB Biotechnologies
  • Pierre Fabre
  • Pierre Fabre Medicament
  • Sanofi Pasteur MSD
  • Sanofi Pasteur Siege mondial
  • Sanofi-Synthelabo Groupe
  • Schering-Plough

Denmark

  • Ferring Pharmaceuticals
  • Ferring Pharmaceuticals A/S
  • Ferring Pharmaceuticals.
  • H. Lundbeck A/S
  • Larix
  • LEO Pharma
  • Leo Pharma A/S
  • MERCK SHARP & DOHME
  • Novo Nordish A/S
  • Novo Nordisk
  • Novo Nordisk A/S

Ireland

  • Athlone Laboratories
  • Ferring Ireland Ltd
  • Irotec Laboratories
  • Kora Healthcare
  • NorthStar Healthcare Ltd
  • Ovelle
  • Pfizer Limited
  • Pinewood Healthcare Limited
  • Pinewood Healthcare Ltd.

Spain

  • Faes Farma S.A.
  • Faes Farma SA
  • FERRER INTERNACIONAL S.A.
  • Grupo Ferrer Internacional SA
  • Grupo Ferrer Internaional S.A.
  • Laboratorios Almirall S A
  • Laboratorios Leti SL Unipersonal
  • PHARMACIA SPAIN
  • Reig Jofre Group

Israel

  • Gsap Medlogic
  • Kamada Ltd
  • Maccabi Health Services
  • Maccabi Healthcare Services
  • Teva Pharm Industries Ltd
  • Teva Pharmaceutical Industries Ltd
  • Teva Pharmaceuticals Industries Ltd

Sweden

  • AstraZeneca
  • Astrazeneca R&D
  • Clean Chemical Sweden AB
  • Q-Med AB
  • Sanofi-aventis AB
  • Scientific Solutions Scandinavia AB
  • SOBI

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia
  • Europharma doo
  • Pliva Hrvatska D.O.O.
  • Providens
  • Providens Ltd
  • xellia

Czech Republic

  • Arriello
  • Arriello s.r.o.
  • Baxter Czech spol. S r.o.
  • Teva Czech Industries S R O
  • Zentiva Group AS
  • Zentiva, k.s.

United States of America

  • Abbott Laboratories
  • Aeras Global TB Vaccine Foundation
  • C.B. FLEET COMPANY INC
  • Jazz Pharmaceuticals Inc
  • Next Generation Clinical Research
  • Santen

Saudi Arabia

  • Al Faisaliah Medical Systems
  • Apotex Saudi Arabia
  • SAUDI FOOD & DRUG AUTHORITY
  • Saudi Food and Drug Authority
  • SFH

Austria

  • Baxter Innovations GmbH
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Boehringer Ingelheim Regional Center Vienna GmbH & Co KG
  • Octapharma Pharmazeutika Produktionsges.m.b.H.

Italy

  • AstraZeneca SPA
  • Chiesi Farmaceutici SPA
  • Recordati
  • Warner Chilcott Italy Srl

Russia

  • Amgen LLC
  • Evrokontakt Plus
  • Roche Moscow Ltd.
  • Voyage Tour LLC

Romania

  • Ewopharma AG
  • Romastru Trading Srl
  • Worwag Pharma GmbH & Co. KG

Slovenia

  • Blood Transfusion Centre of Slovenia
  • LEK Pharmaceuticals d.d.
  • Medis, d.o.o

Canada

  • ApoPharma Inc
  • Aspreva Pharmaceuticals Corporation

Finland

  • Orion Corporation Orion Pharma
  • OY LEIRAS FINLAND AB

Lithuania

  • Acorus Calamus
  • UAB Sicor Biotech

Norway

  • Pronova BioPharma Norge AS
  • Targovax ASA

Serbia

  • Medicines and Medical Devices Agency of Serbia
  • Poslovni centar Hemofarm

Slovak Republic

  • Ewopharma International s.r.o
  • Ewopharma International, s.r.o.

Ukraine

  • O & D Pharma
  • Schering-Plough CE AG

Albania

  • Promed

Algeria

  • AVENTIS PHARMA

Argentina

  • Seqirus

Brazil

  • Natura Inovacao Tecnologia de Produtos Ltda.

Bulgaria

  • ACTAVIS EAD

Estonia

  • Vitale-XD Ltd

Greece

  • AstraZeneca SA

India

  • DR Reddys Laboratories Ltd

Iran

  • Cobel Darou

Iraq

  • United Nations

Japan

  • Clinipace Wordwide

Korea, Democratic People's Republic Of

  • Archigen Biotech Limited

Korea, Republic Of

  • Korea Food & Drug Administration

Kuwait

  • Al Hafez Trading Est

Moldova

  • Balkan Pharmaceuticals

Taiwan

  • Taiwan Drug Relief Foundation

Turkey

  • Novo Nordisk

Run Pharmacovigilance Bespoke training for your team

3 days

Typical duration

Pricing from:

  • GBP 1,200
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy