Agenda

Amsterdam, 22 - 23 September 2020

Schedule

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Sep 2208:45
Conference pass

Chair’s opening remarks

Keynotes
Patrick Caubel, Senior Vice President, Pharmacovigilance, Pfizer
Sep 2208:50
Conference pass

Title TBC

Keynotes
Raj Long, Deputy Director, Integrated Development, Global Health, The Bill & Melinda Gates Foundation
Sep 2209:30
Conference pass

Title TBC

Keynotes
Jens-Ulrich Stegmann, Vice President, Head Clinical Safety And Pharmacovigilance Gsk Vaccines And Eu Qppv, Viiv Healthcare, G.S.K Biologicals
Sep 2211:15
Conference pass

Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process

AI + Automation
Kristof Huysentruyt, Director, Head Of Safety Data Management And Technology, UCB
Sep 2211:15
Conference pass

Title TBC

Risk Management
Stewart Geary, Senior Vice President, Chief Medical Officer, Director, Corporate Medical Affairs Headquarters, Eisai
Sep 2211:15
Conference pass

Challenges and opportunities for Global Process Owners in end-to-end signal management process

Signal Detection & Management
Jeremie Dedessus Le Moutier, Head Of Pharmacovigilance Excellence And Compliance, GSK
Sep 2211:15
Conference pass

Training in PV: what is the difference between necessity, comfort and luxury

Quality Assurance & Compliance
Ranjana Khanna, Director, Head Of Pv Quality Assurance, Vifor Pharma
Sep 2211:15
Conference pass

How to take control of the various (non-traditional) sources of AE info

Case Processing
  • Especially with patient centric organizations there are increasing variety of initiatives to connect with patients and HCPs, with a high potential of missed AE reporting. A story of how Alexion dealt with that challenge.
Mariette Boerstoel-Streefland, Senior Vice President Of Pharmacovigilance And Drug Safety, Alexion Pharmaceuticals
Sep 2211:15
Conference pass

Patient involvement in PV

Patient Advocacy & Centricity
Paola Kruger, Patient Expert, Eupati
Sep 2211:55
Conference pass

Roundtables (AI + Automation)

AI + Automation
Application of blockchain in the pharmaceutical industry and pharmacovigilance
Kate Gofman, Global Safety Physician, Artificial Intelligence And Blockchain Innovator, AstraZeneca
Digital therapeutics: How Older Adults can benefit from Technical Innovations
Antonia K Coppin-Renz, Director, Therapeutic Area Lead Digital Therapeutics And Deputy EU QPPV, Otsuka Europe
How safety physicians feel about automation: positives, future and threats
Howard Snow, Howard Snow, Head Patient Safety, Sandoz Biopharmaceuticals, Chief Medical Office And Patient Safety, Novartis International AG
Sep 2211:55
Conference pass

Roundtables (Risk Management)

Risk Management
How are companies utilising development RMP's?
Philippa Evans, Safety Medical Writer, Novo nordisk
Local Implementation of Risk Minimisation Activities
John Solomon, Head Of Pharmacovigilance, Sanofi
Sep 2211:55
Conference pass

Roundtables (Signal Detection and Management)

Signal Detection & Management
Signal Detection for Orphan Drugs (quantitative vs qualitative approaches)
Marco Sardella, Chief Pharmacovigilance Officer And Q.P.P.V. For Europe, Adienne
Signal detection in small to medium-sized companies
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 2211:55
Conference pass

Roundtables (Quality Assurance + Compliance + Regulation)

Quality Assurance & Compliance
Challenges of Global PV function in a changing business environment – how to ensure efficient collaboration between global and local teams?
Attila Olah, Head Global Pharmacovigilance, Eu-Qppv, Gedeon Richter PLC
Maintenance of a worldwide PSMF
Margherita D'Antuono, E.U. Q.P.P.V., Italfarmaco S.P.A.
Gabrielle Amselem, Deputy Qppv And Psmf Manager, Alexion Pharmaceuticals
Monika Manske, Associate Director Of Global Pharmacovigilance Governance, Mylan
Preparing for Inspections 
Raj Bhogal, Director, Safety And International, Regulatory Inspections And Global Quality, Takeda
Regulation in LATAM and how to harmonise globally to match Europe and its regulations
Erick Said Ponce Riaño, Global Pharmacovigilance and Risk Management. LATAM Regional Specialist, Bausch Health
Sep 2211:55
Conference pass

Roundtables (Case Processing + Translational Safety)

Case Processing
Bridging non-clinical and clinical safety: enhancing confidence in using state-of-the art safety pharmacology approaches
Jean-Pierre Valentin, Head Of Investigative Toxicology, Ucb Belgium
Frederick Sannajust, Former Executive Director Of Safety and Exploratory Safety Pharmacology At Merck, Independent Consultant, Independent Consultant
How to expand a safety department
Safety Data Exchange Agreements
Nadia Espanol, Global Medical Safety Manager, Associate Director, Galapagos
Sep 2211:55
Conference pass

Roundtables (Patient Advocacy + Centricity + Cell and Gene Therapy)

Patient Advocacy & Centricity
Patient Centricity
Mary Lynne Van Poelgeest-Pomfret, President, President of the World Federation for Incontinence and Pelvic Pain - WFIP
Patient information requirements for GCC
Rama Albouaini, Senior Regulatory Affairs Manager, Mena, NewBridge Pharmaceuticals
Sep 2213:45
Conference pass

Chair’s Remarks

AI + Automation
Priya Singhal, Head Of Research And Development, Zafgen, Inc.
Sep 2213:45
Conference pass

Chair’s Remarks

Risk Management
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 2213:45
Conference pass

Chair’s Remarks

Signal Detection & Management
Heike Schoepper, Vice President, Head Of Business Unit For Consumer Healthcare, Sanofi
Sep 2213:45
Conference pass

Chair’s Remarks

Case Processing
Heike Von Treichel, Head Of Qualified Person For Pharmacovigilance Office, Merck
Sep 2213:50
Conference pass

Assessing the effectiveness of risk minimisation

Risk Management
Liana Gross Martirosyan, Alternate Prac Member, Netherlands
Sep 2213:50
Conference pass

Title TBC

Signal Detection & Management
Sutirtha Mukhopadhyay, Global Safety Officer, Ablynx
Sep 2213:50
Conference pass

PV agreements: Managing business relationships

Quality Assurance & Compliance
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Sep 2213:50
Conference pass

Market Research Programs and Patient Support Programs: challenges and expectations

Case Processing
Daniela Di Cosmo, Pharmacovigilance Manager, FERRING Pharmaceuticals
Sep 2213:50
Conference pass

Real world data: are you sure you have the relevant data?

Patient Advocacy & Centricity
Dominique Hamerlijnck, Patient Experience Expert, Innovative Medicines Initiative
Sep 2214:30
Conference pass

Augmented Intelligence and the evolving role of the PharmacoVigilance professional

AI + Automation
Salvatore Cicirello, Senior Director, Pharmacovigilance Innovation, Celgene
Sep 2214:30
Conference pass

Risk management and planning in Orphan Drugs

Risk Management
Marie Aavang Geist, Head Of Clinical Safety, Orphazyme
Sep 2214:30
Conference pass

Interim results of a PASS on the incidence of thromboembolic events in patients taking Selective Estrogen Receptors Modulators (SERM)

Signal Detection & Management
Fabio De Gregorio, Vice President And Head Of Drug Safety, Shionogi Ltd
Sep 2214:30
Conference pass

Inspection Preparedness

Quality Assurance & Compliance
Jaylaxmi Nalawade, Associate Director, Lupin Ltd
Sep 2214:30
Conference pass

Digital Media and e-commerce initiatives: challenges for PV

Case Processing
Valentina Mancini, EU QPPV, Shionogi Pharmaceuticals Europe
Sep 2214:30
Conference pass

Pharmacovigilance and patient safety: Trends of a new decade

Patient Advocacy & Centricity
Patricia Zuluaga Arias, Board of Directors, Coordinator of Academic Committee, Colombian Pharmacovigilance Association
Sep 2214:50
Conference pass

Chair’s Remarks

AI + Automation
Priya Singhal, Head Of Research And Development, Zafgen, Inc.
Sep 2214:50
Conference pass

Chair’s Remarks

Risk Management
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 2214:50
Conference pass

Chair’s Remarks

Signal Detection & Management
Heike Schoepper, Vice President, Head Of Business Unit For Consumer Healthcare, Sanofi
Sep 2214:50
Conference pass

Chair’s Remarks

Case Processing
Heike Von Treichel, Head Of Qualified Person For Pharmacovigilance Office, Merck
Sep 2214:55
Conference pass

Risk based auditing

Risk Management
Maha Saad, Americas Pharmacovigilance Head, Bioresearch Quality And Compliance, Quality Assurance, Johnson & Johnson
Sep 2214:55
Conference pass

Key lessons learnt from Grünenthal’s newly implemented signalling process

Signal Detection & Management
Fabian Heisig, Head Of Safety, Benefit Risk And Global Drug Safety, Grunenthal
Sep 2214:55
Conference pass

The local QPPV’s Value in a Global PV System

Quality Assurance & Compliance
Eva Van Engelen, Associate Director Pharmacovigilance And Epidemiology, Gilead Sciences
Sep 2214:55
Conference pass

Establishing a PV affiliate management function under a global mixed-model commercial environment

Case Processing
Keya Pitts, Head, Quality, Standards, And Compliance, Global Patient Safety And Risk Management, Alnylam Pharmaceuticals
Sep 2215:15
Conference pass

Panel: Operationalising automation in PV

AI + Automation
Arvind Bellur, Senior Director, Head Of Safety Data Management, Sanofi
Sep 2215:15
Conference pass

Showcase session: ‘Brexit Panel’

Patient Advocacy & Centricity
John Solomon, Head Of Pharmacovigilance, Sanofi
Phil Tregunno, Group Manager, Vigilance, Intelligence And Research, Medicines & Healthcare Products Regulatory Agency
Belen Granell Villen, Quality And Safety Policy Executive, ABPI
Sep 2215:35
Conference pass

Secondary Pharmacology Screening in Pharmaceutical R&D: A survey of practices and experiences across 18 companies

Risk Management
Richard Brennan, Scientific Advisor, SANOFI
Sep 2215:35
Conference pass

Signal Detection from early clinical development to first label

Signal Detection & Management
Kristina Strutt, Head Of Pharmacovigilance, General Medicines And Emerging Markets, Sanofi
Sep 2215:35
Conference pass

Building in quality to ensure "getting it right first time"

Quality Assurance & Compliance
Leona Houghton, Senior Director, Global Head Pharmacovigilance Quality And Compliance, Jazz Pharmaceutical
Sep 2215:35
Conference pass

Hints and Tips for a major Safety Database update from the perspective of a mid-size pharma

Case Processing
Albert Bekfi, Head Of Global Pv Operations, Gedeon Richter PLC
Sep 2216:25
Conference pass

Chair's Remarks

Translational Safety
Scott Chandler, Global Head, Personalized Health Care (PHC) Safety, F. Hoffmann - La Roche
Sep 2216:25
Conference pass

Chair's Remarks

Cell & Gene Therapy
David Chonzi, Vice President, Head Of Pharmacovigilance And Epidemiology ( Pve), Allogene Therapeutics
Sep 2216:30
Conference pass

WEB-RADR Update

AI + Automation
Phil Tregunno, Group Manager, Vigilance, Intelligence And Research, Medicines & Healthcare Products Regulatory Agency
Sep 2216:30
Conference pass

Title TBC

Risk Management
Shahram Khanzadeh, Medical Director Safety And Pharmacovigilance, Arena Pharmaceuticals
Sep 2216:30
Conference pass

The use of longitudinal data for raising signals to EMA/PRAC

Signal Detection & Management
Kare Kemp, Senior Head Of Pharmacovigilance Advisor, Team Leader And Section And Safety, Laegemiddelstyrelsen
Sep 2216:30
Conference pass

Processing of direct healthcare professional communications (DHPCs)- same letter in different regions, EU and non EU

Regulation
Tatjana Ajhler Duretek, Head Of Medical Affairs And Pharmacovigilance, Belupo
Sep 2216:30
Conference pass

Panel: Translational Methodologies and Predictive Safety

Translational Safety
Scott Chandler, Global Head, Personalized Health Care (PHC) Safety, F. Hoffmann - La Roche
Andrew Olaharski, Senior Director And Head Of Toxicology, K.S.Q. Therapeutics
Andrew Erdman, Vice President, Global Head Of Early Development Safety, Genentech
Sep 2216:30
Conference pass

Post marketing experience from CAR Ts

Cell & Gene Therapy
Paul Wang, Director Of Pharmaco Vigilance Operations, Kite Pharma, a Gilead Company
Sep 2216:50
Conference pass

Challenges in the evaluation of SCAR Safety Signals

Signal Detection & Management
Petar Gjorgiev, Global Safety Physician, Amgen
Sep 2217:10
Conference pass

Chair's Remarks

Translational Safety
Scott Chandler, Global Head, Personalized Health Care (PHC) Safety, F. Hoffmann - La Roche
Sep 2217:10
Conference pass

Chair's Remarks

Cell & Gene Therapy
David Chonzi, Vice President, Head Of Pharmacovigilance And Epidemiology ( Pve), Allogene Therapeutics
Sep 2217:15
Conference pass

Vigilance in the era of digital media

AI + Automation
Belen Granell Villen, Quality And Safety Policy Executive, ABPI
Sep 2217:15
Conference pass

What can we learn from quantification for benefit risk and is it applicable today?

Risk Management
Israel Gutierrez, Vice President Pharmacovigilance And Drug Safety, Geron Corporation
Sep 2217:15
Conference pass

The Eudravigilance Signal Detection Pilot, the implementation and its results in one company and the second prolongation of the pilot, sense or nonsense

Signal Detection & Management
Bert Van Leeuwen, Deputy Qppv, Astellas Pharma Europe BV
Sep 2217:15
Conference pass

Managing pharmacovigilance compliance in an uncertain regulatory world, the issues of managing change

Regulation
Jackie Roberts, Vice President Scientific Affairs, Governance, Accord Healthcare
Sep 2217:15
Conference pass

Drug-induced QTc prolongation and torsades de pointes: evolving ICH-E14 and S7B guidelines in light of emerging data

Translational Safety
Jean-Pierre Valentin, Head Of Investigative Toxicology, Ucb Belgium
Sep 2217:15
Conference pass

Title TBC

Cell & Gene Therapy
Ale Maria Vazquez-Gragg, Vice President Of Global Patient Safety, Argenx
Sep 2217:35
Conference pass

Title TBC

Signal Detection & Management
Petar Gjorgiev, Global Safety Physician, Amgen
Sep 2217:55
Conference pass

The nocebo effect paradox induced by communicating information on adverse drug reactions

Risk Management
Giovanni Furlan, Director And Safety Risk Lead, Pfizer
Sep 2217:55
Conference pass

Quality tolerance limits: supporting signal detection processes through the use of AE and SAE reporting rate parameter

Signal Detection & Management
Ruma Bhagat, Senior G.C.P. Strategy Lead And Site Innovation Group Lead, Genentech, Inc. (A member of the Roche Group)
Shaun V Mohan, Md, Genentech, Inc. (A member of the Roche Group)
Sep 2217:55
Conference pass

Regulation alignment in global clinical investigations. Complex Safety Reporting in worldwide medical device studies

Regulation
Sylvie Bartus, Safety Global Clinical Affairs Director, Edwards Life Sciences
Sep 2217:55
Conference pass

Drugs can fail because of effects on arterial blood pressure - how can we improve the preclinical predictivity of drug-induced hemodynamic changes?

Translational Safety
Frederick Sannajust, Former Executive Director Of Safety and Exploratory Safety Pharmacology At Merck, Independent Consultant, Independent Consultant

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Sep 2311:10
Conference pass

Chair's Remarks

AI + Automation
Omar Aimer, PV spécialiste, Brunel Canada
Sep 2311:15
Conference pass

Regulatory Issues of Pharmacoepidemiology

Regulation
Doris Stenver, Former Chief Medical Officer, Member Of Prac At Ema, Danish Medicines Agency
Sep 2311:15
Conference pass

Use cases in drug safety and what lessons we can learn from those

RWE & Big Data
Anupam Agarwal, Vice President Global Head Of Drug Safety And Pv, Zogenix
Sep 2311:15
Conference pass

Title TBC

PV Outsourcing
Manni Kuthiala, Pv Affiliate Strategic Alliance Manager, Roche
Sep 2311:55
Conference pass

Roundtables (Regulation + Developing Markets)

Regulation
How ICH can bring divergence in some points
Raphael Pareschi, Pharmacovigilance Associate Director, Pv Country Lead Deputy, Merck
Inspection management: Inspection readiness & conduct in global organisations and navigating through the challenges
Smruti Kothari, Associate Director, Pv Quality Operations, Alexion Pharmaceuticals
New challenges for PV in Mexico
Rodrigo Ruiz, Head Of Country Pharmacovigilance Mexico, Bristol-Myers Squibb
Sep 2311:55
Conference pass

Roundtables (PV Outsourcing + Condition Specific Therapies)

PV Outsourcing
Drug Safety In Biosimilars and Biologics
Yvonne Nanciu, Senior Manager - Pharmacovigilance And Medical Information, AbbVie
Sep 2311:55
Conference pass

Roundtables (Safety & Labelling + Medical Devices)

Medical Devices
Developing a map for clinical device safety and how to cover all aspects (workshop exercise)
Sylvie Bartus, Safety Global Clinical Affairs Director, Edwards Life Sciences
Drug-Device Combination Products: How the evolving global regulatory landscape will impact PV operations
Tarik Messaoud, Drug Safety Specialist Pharmacovigilance Specialist, Independent
Impact of FDA PMSR and EU MDR regulations on reference safety information table for combination products
Maritess Esguerra, Principal Pharmacovigilance Process Leader, Genentech
Labelling in Non-EU Countries
Marjan Dzeparoski, Ra And Pv, Bionika Pharmaceuticals
Sep 2313:45
Conference pass

Regulations and Standards in Asia: Challenges and new trends

Regulation
Gloria Bustos, Head Of Pharmacovigilance Emea And Apac, Baxter Corp
Sep 2313:45
Conference pass

Social media from a Pharmacovigilance prospective

RWE & Big Data
Andrea Oliva, Head Of Pharmacovigilance, Mylan Inc.
Sep 2313:45
Conference pass

Ensuring Effective Sponsor-Vendor Relationships 

PV Outsourcing
Hal Ward, Vice President Of Drug Safety, Kyowa Hakko Kirin Co Ltd
Sep 2313:45
Conference pass

Achieving holistic Patient Safety – How AZ approached incorporating Device Requirements into our Pharmacovigilance System

Medical Devices
James Whitehead, Patient Safety Medical Device Lead, Astra Zeneca
Sep 2314:25
Conference pass

How to create an effective PV strategy?

Regulation
Julia Appelskog, Head Of Pv Strategy, Merck Group
Sep 2314:25
Conference pass

Title TBC

PV Outsourcing
András Lehoczki, Director Global Drug Safety Head Data Operations, Grünenthal USA
Sep 2315:15
Conference pass

Chair's Remarks

Labelling & Serialisation
Marjan Dzeparoski, Ra And Pv, Bionika Pharmaceuticals
Sep 2315:20
Conference pass

Pharmacovigilance Risk Management Plan. Risk Minimization Action Plan (RiskMAP) for a new approval medicine.

Risk Management
Jorge González Borroto, Senior Toxicologist & Nonclinical Safety Adviser, Ferrer Advanced Therapeutics
Sep 2315:20
Conference pass

Specific challenges of exposure through pregnancy to vaccines and biological products

Condition Specific Therapy Areas
Francoise Sillan, Head Of European Safety Office, Deputy Qualified Person Responsible For Pharmacovigilance And, Pfizer
Sep 2315:20
Conference pass

Challenges of implementing PV process in Mena Region

Developing Markets
Muhammad Ashar Naeem, Global Director Pharmacovigilance And Medical Affair, Jamjoom Pharma
Sep 2315:20
Conference pass

Outlook of e-labelling

Labelling & Serialisation
Rie Matsui, Director, Regional Labeling Head Of Asia, Pfizer
Sep 2315:40
Conference pass

Title TBC

Risk Management
Peter De Veene, Qppv, Alexion Pharmaceuticals
Sep 2315:40
Conference pass

Practical Approach: End to end management of safety updates- Signal to Label

Labelling & Serialisation
Vishakha Oza, Senior Scientist, Nerve Care Franchise, Procter & Gamble
Sep 2316:00
Conference pass

Title TBC

Risk Management
Haris Shaikh, Senior Director Pharmacovigilance, Orchard Therapeutics
Sep 2316:00
Conference pass

Drug safety: unique solutions for unique challenges in Sub-Saharan Africa

Developing Markets
Mary Ngome, Head Of Medical, Regulatory, Quality Affairs And Pharmacovigilance, Middle Africa, Novo nordisk
last published: 31/Mar/20 12:05 GMT

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