Pharmacovigilance Europe Congress 2018

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Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.[1] The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation[2]). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.[3]

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse event reporting below.)

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.[4] Pharmacovigilance Europe Congress 2018 is the 4th Annual International Conference and Exhibition in Pharmacovigilance, Clinical Trials, Regulatory Affairs and Risk Management. This event attracts attendees from pharmaceutical, biopharmaceutical, biotechnology, diagnostics, CRO and solution provider companies. Pharmacovigilance Europe congress represents a great opportunity to update with the expanding Global Pharmaceutical Industry and increase awareness on the increasingly more essential need of Global Pharmacovigilance. It is also an excellent chance for networking and knowledge sharing and experience. [1]

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Pharmacovigilance Europe Congress 2018
Date 2017-07-19
Place Kensington High Street, Wrights Lane, London, UK

Event topics

The rapid growth of pharmaceutical industries has resulted in innovations and increase in the number of drugs into the market, which has also resulted in the rise of adverse drug events. These events have led to a rise in public safety concerns, stringent regulatory policies, expectations and tough inspection regimes, providing the much-needed stimulation for the growth of pharmacovigilance market. The field of drug safety reporting has been extended to medical devices, traditional medicines and biologics. The Pharmacovigilance Europe 2018 conference will participants an opportunity and a platform to share experiences with the like-minded individuals in the field. The conference will bring together industry experts and regulators to discuss the new updates in EU legislation, operational challenges of an implication of these changes, the experience of implementing global risk management plans, the best and effective way forward, the impact of IT and social media on PV and harmonization of different regulatory bodies. [2]

Information: If you would like to register for this conference, or obtain further information or a letter of invitation to this conference, please follow the links above. The Conference Website service does not accept bookings for conferences, travel arrangements, housing or accommodation. Please follow the links above for the relevant conference information.

Key Theme 1.Explore the impact of PV legislation changes and updates on industries and the best practices 2.Assuring Compliance and its monitoring 3.Preparing for PV audit and inspections and the role of QPPV 4.Risk management plans, strategies and new risk- benefit analysis tools to improve REMS reporting 5.Implementing risk management and safety surveillance methodologies for medical devices 6.New approaches for risk minimization and communication 7.Determining steps and strategies for more transparency and involvement of patients 8.Discussing the how IT and Social media effect Pharmacovigilance and Adverse events reporting 9.Discuss and review the use of databases and emerging tools for generation and detection of safety signals 10.Importance of outsourcing and its effectiveness 11.Harmonization of regulatory framework- developed and emerging markets [3]

Day 1 8.30 - 9.30

Registration & Refreshments

9.30 - 9.45

Chair Person Opening Remarks Susan Welsh MD Chief Safety Officer, CSL Behring 9.45 - 10.30

Risk Management Heike Schoepper VP, Head of GDS-PV Management Biopharma | Research & Development | Global Medical Affairs and Global Drug Safety Merck 10:30 - 11:00

How QA department can support PV department(s) implementing the changes in regulation?

Lynn Moati PV QA Manager, Norgine

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00

PV Systems Inspections

Raj Bhogal Safety & International Director, Regulatory Inspections, R&D QA & Compliance, Shire Pharmaceuticals 12:00 – 12:30

Role of Artificial Intelligence in PV Niraj Chhaya Lead Risk Management, Global Pharmacovigilance Boehringer Ingelheim

12:30 – 13:30

Networking luncheon

13:30 – 14:00

CRO'S views on PV Outsourcing ICON - Premium Sponsor of PV Europe 2018 14:30 – 15:00

Utilising Digital Patient Experience to improve Products and Communication Dr. Dirk Schachtner Executive Officer, Consline AG

15:00 – 15:30

Afternoon Tea/Coffee 15:30 – 16:00

Role of PV in Biologics Mark Bailey. Global Safety Manager, Amgen 16:00 – 16:45

Panel Discussion PRAC Strategies to measure the Impact Factor of Pharmacovigilance

16:45 – 17:00

Chairperson’s closing remarks 17:00 – 18:00

Networking Drinks Reception

8.30 - 9.30

Registration & Refreshment

9.30 - 9.45

Chairperson's opening remarks Susan Welsh MD Chief Safety Officer , CSL Behring

9.45 - 10.30

MAHs access to and obilgations in Eudravigilance, First Experiences Bert Van Leeuwen QPPV Astellas 10:30 - 11:00

GVP IX - updates related to signal management David Lewis Global Head of Pharmacovigilance ,Novartis

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00

PV inspections - where are we now - GXP inspection types and pharmacovigilance - Different inspectorates methods and approaches - Where to next?... status quo or time for change? Andrew Cooper PVQA Manager GQA - CDQA Pharmacovigilance QA R&D Chief Regulatory Office GSK

12:00 – 12:30

Do we correctly communicate the risks of medicines and vaccines to the general public? Giovanni Furlan Senior Director Pharmacovigilance & Risk Management, EU QPPV Seqirus

12:30 – 13:00

Benefit-Risk Assessments - what is required from the regulatory perspective? Bettina Doepner Director, EU Therapeutic Area Lead Critical Care Global Regulatory Affairs CSL Behring

13:00 – 14:00

Networking luncheon

14:00 – 14:30

All Safety Variations Sources : Keeping Generic Product Information up to date Tatjana Ajhler Duretek Head of Medical Affairs and Pharmacovigilance, Belupo

14:30 – 15:00

Topic TBC Mircea Cicua Head of Global Drug Safety, Vifor Pharma

15:00 – 15:30

Afternoon Tea/Coffee

15:30 – 16:00

Brexit and the Impact on Pharmacovigilance Jackie Robert Executive Director - Regulatory, PHV and Medical Accord Heathcare

16:00 – 16:45

Panel Discussion & Speak Out Session - HOT Topics Patient Support Programme Medication Errors Off Label Usage

16:45 – 17:00

Chair person’s closing remarks and end of conference

Conference Venue

Kensington High Street, Wrights Lane, London, UK Hilton London Olimpia


Pharmacovigilance Europe Congress 2018 attracts senior level attendees from leading pharmaceutical, biopharmaceutical, biotechnology, diagnostics, CRO and solution provider companies. Delegates includes VPs, Directors, Heads, Managers, Scientific Advisors, Consultants, Senior scientists and professionals with intermediate to advance knowledge and experience in the following

Why Should You Attend Pharma/BioTech companies are always faced with the challenge to improve quality of the safety data with the ever-increasing quantity of the data. The companies are also left with the challenge to manage the dynamic regulatory requirements. There are still many complexities that the industries and the regulatory authorities have to tackle. With more communication and networking you can expand your knowledge on the key complications currently experienced by various industries and departments and design new strategies to overcome the same

Top speakers

  • Heike Schoepper - VIP and Head - Global Patient Safety
  • Susan Welch - Chief Safety Officer - CLS Behring
  • Raj Bhogal - Safety & International Director, R&D, QA & Compliance - Shire
  • David Lewis - Global Head of Pharmacovigilance - Novartis
  • Andrew Copper - PV Quality Assurance- GSK
  • Bettina Doepner - Director Regulatory Affairs - CSL Behring
  • Mark Bailey - Global Safety Manager - Amgen
  • Bert Van Leuven - QPPV Pharmacovigilance - Astellas
  • Lynn Moati - Associate Director PV Quality Assurance - Norgine
  • Niraj Chhaya - Lead Risk Management Global Pharmacovigilance - Boehringer Ingelheim [4]

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