Great content and very well attended by industry experts

President, AgilePV

 

Amsterdam, 10 - 11 September 2018

Schedule

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Sep 1008:50
Conference pass

Chair’s opening remarks

Keynotes
Sep 1009:00
Conference pass

Innovation in PV

Keynotes
Felix Arellano, Global Head Pharmacovigilance and Drug Safety, Roche
Sep 1009:20
Conference pass

Global Clinical Trials and the complexities of Reference Safety Information (RSI)

Keynotes
  • Overview of the changing landscape related to RSI
  • Perspectives on navigating RSI complexities in light of new EU requirements
  • Potential approaches for consideration in context of global clinical trial conduct
Sep 1009:40
Conference pass

Developments in drug safety for biologics

Keynotes
Jens-Ulrich Stegmann, Vice President Head Clinical Safety and Pharmacovigilance, G.S.K Biologicals
Sep 1011:40
Conference pass

Roundtables

Keynotes
Achieving effective service provider management
Ricarda Tiemeyer, Head of Drug Safety, Roche Pharmaceuticals Sa
AI and big data in drug safety
Nina Jeliazkova, Technical Manager, Idea Consulting
Mark Cronin, Professor of Predictive Toxicology, Liverpool John Moores University
Romualdo Beningni, Consultant, alpha-pretox
Are post-marketing questionnaires valuable?
Fernando Solimando, Senior Risk Management Physician, Boehringer Ingelheim
Brexit: Where next?
David Jefferys, Senior Vice President, Eisai Medical Research
Different approaches - signal detection for small to medium companies
Sutirtha Mukhopadhyay, Associate Director of Pharmacovigilance, Ablynx
Examining the challenges of updating risk management plans in line with revision II of GVP V
Liana Gross Martirosyan, Senior Pharmacovigilance Assessor, Dutch Medicines Evaluation Board
Examining the Pharmacovigilance System Masterfile and licensing pharma audit
Monika Manske, Associate Director of Global Pharmacovigilance Governance, Mylan
How to manage a pharmacovigilance crisis in the XXI century?
Improving local drug safety processes
Miroslava Novakova, DSM, G.S.K.
Outsourcing in PV
Katrien Soleme, Senior Compliance Specialist, Global Quality Regulatory Compliance & Clinical Trials & Safety, Bristol Myers Squibb
PV considerations in market research and patient support programs
PV considerations in social media
Leatesh Patel, Senior Pharmacovigilance Manager, Biogen Idec
Quantitative benefit-risk assessment: where are we today?
Reduction of avoidable medical related harm
Jayne Lawrence, Head of Division of Pharmacy and Optometry, University of Manchester
Sunayana Shah, Head of regulatory and safety policy, Association of the British Pharmaceutical Industry
The new eudravigilance: process changes and best practices
Francesco Tescione, EU Qualified Person for Pharmacovigilance QPPV, Molteni Farmaceutici
Sep 1013:30
Conference pass

Chair’s remarks

Signal Detection & Management and Safety in Medical Devices
Sep 1013:30
Conference pass

Chair’s remarks

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Emanuel Lohrmann, Lead Safety Physician, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 1013:30
Conference pass

Chair’s remarks

Big Data and AI in Safety, Regulation and Case Processing
Howard Snow, Vice President of Drug Safety and Epidemiology, Novartis International AG
Sep 1013:30
Conference pass

Chair’s remarks

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Celine Adessi, Senior Group Director, Clinical Safety Science Oncology, Roche
Sep 1013:35
Conference pass

Latest developments in signal management

Signal Detection & Management and Safety in Medical Devices
Mircea Ciuca, Head of Medical and Clinical Drug Safety, Vifor Pharma
Sep 1013:35
Conference pass

Polypill-TRINOMIA: New Cardiovascular Fixed-Drug Combination Developed with Efficacy and Safety in Mind. Pharmacovigilance Safety Data in Real World

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Jorge González Borroto, Pharmacovigilance Officer/Senior Toxicologist, Ferrer Internacional, S.A.
Sep 1013:35
Conference pass

Developments in innovative technology for drug safety

Big Data and AI in Safety, Regulation and Case Processing
Salvatore Giorgio Cicirello, Senior Director Pharmacovigilance Innovation, Global Drug Safety & Risk Management, Celgene
Sep 1013:35
Conference pass

“Orphanizing” NSCLC: Subsetting for more targeted, more effective and less toxic therapies: EGFR and ALK

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
  • Chemotherapy for NSCLC
  • NSCLC subsets (EGFR and ALK)
  • Targeted therapy for NSCLC subsets: efficacy, toxicity, class effects
Dennis Vargo, Global Safety Lead, Takeda Pharmaceutical Company
Sep 1013:55
Conference pass

Pharmacogenomics in Post-Marketing Pharmacovigilance

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Sep 1014:15
Conference pass

Employing quantitative tools to support signal detection

Signal Detection & Management and Safety in Medical Devices
Christina Virkelyst Tvermoes, Head PV Science, LEO Pharma
Sep 1014:15
Conference pass

A Merck Case Study into risk management

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Matthias Boedding, Senior Director, Merck Group
Sep 1014:15
Conference pass

Latest developments for global standards on safety in oncology

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Fatima Yousef, Head Of Quality and Medication Safety unit, King Abdullah International Medical Research Center KAIMRC
Sep 1014:35
Conference pass

Working with vendor providers to support signal detection capabilities

Signal Detection & Management and Safety in Medical Devices
Simon Ashworth, VP, EU Qualified Person for Pharmacovigilance (QPPV) and Head EU Compliance and Marketed Products, Takeda Development Centre Europe
Sep 1014:35
Conference pass

Automation in case handling activities

Big Data and AI in Safety, Regulation and Case Processing
Andrew Finlay, Pharmacovigilance Excellence Principal, AstraZeneca
Sep 1014:35
Conference pass

Nature of drug safety work in the pre-clinical/clinical transition and early clinical development phase

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Steffen Ernst, Senior Safety Medical Director CVMD, AstraZeneca
Sep 1015:25
Conference pass

Chair’s remarks

Signal Detection & Management and Safety in Medical Devices
Sep 1015:25
Conference pass

Chair’s remarks

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Fabio De Gregorio, Vice President, Head of Drug Safety EU, QPPV, Shinogi Pharmaceuticals
Sep 1015:25
Conference pass

Chair’s remarks

Big Data and AI in Safety, Regulation and Case Processing
Sep 1015:25
Conference pass

Chair’s remarks

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Jorgen Matz, Head of Global Pharmacovigilance and Drug Safety, Insud Pharma
Sep 1015:30
Conference pass

Predictive Signaling

Signal Detection & Management and Safety in Medical Devices
Saeed Amin, Director, Global Head Safety Data Management, US Head Global Pharmacovigilance Compliance & Business Management, Otsuka
Sep 1015:30
Conference pass

Structured Benefit-Risk Assessments in the regulatory context

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Sep 1015:30
Conference pass

Using informatics within a global standardized environment

Big Data and AI in Safety, Regulation and Case Processing
Elena Davison, Director of Global Pharmacovigilance Informatics, Sunovion Pharmaceuticals
Sep 1015:30
Conference pass

Establishing an effective vendor management strategy

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Julie Wilson, Global Head, Safety Evaluation & Reporting, Johnson & Johnson
Sep 1016:10
Conference pass

The role of risk management within signal detection

Signal Detection & Management and Safety in Medical Devices
Marcus Schartau, Safety Surveillance Risk Management Specialist, Safety Surveillance, Novo Nordisk A/S
Sep 1016:10
Conference pass

Evaluating the effectiveness of risk minimization activities

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Sep 1016:10
Conference pass

Utilizing Big Data to make benefit-risk decisions

Big Data and AI in Safety, Regulation and Case Processing
  • What is Big Data?
  • Methods to effectively leverage Big-Data in Safety
  • The role of Big Data for Benefit-Risk decision making
Priya Singhal, Global Head, Senior Vice President, Safety and Benefit Risk, Biogen
Sep 1016:10
Conference pass

Ensuring quality oversight in PV vendor management

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Keya Pitts, Global Head of PV Q/A, Astellas
Sep 1016:30
Conference pass

TBC

Signal Detection & Management and Safety in Medical Devices
Fabian Heisig, Head Of Safety, Benefit Risk And Global Drug Safety, Grunenthal
Sep 1016:30
Conference pass

Effectiveness of complex additional risk minimization measures – A success story

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Amgad Shebl, Director of Global Clinical Safety and Pharmacovigilance, CSL Behring
Sep 1016:30
Conference pass

Innovation in benefit-risk evaluation present and future

Big Data and AI in Safety, Regulation and Case Processing
  • Among Regulators, HTAs, industry and academia, Benefit-Risk evaluation has shifted into a more structured and quantitative approach
  • The role of patient preference in the medicinal product decision-making, including Benefit-Risk evaluation, has significantly increased
  • Given this shift, various innovative methods of quantitative Benefit-Risk evaluation and patient-preferences have been evaluated in various public-private initiatives
Juhaeri Juhaeri, VP and Head, Global Safety Sciences, Sanofi
Sep 1016:30
Conference pass

Implementing effective standards in PV outsourcing

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Bert van Leeuwen, deputy QPPV, Astellas Pharma Europe BV
Sep 1017:20
Conference pass

Chair's remarks

Signal Detection & Management and Safety in Medical Devices
Sep 1017:20
Conference pass

Chair’s remarks

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Fabio De Gregorio, Vice President, Head of Drug Safety EU, QPPV, Shinogi Pharmaceuticals
Sep 1017:20
Conference pass

Chair’s remarks

Big Data and AI in Safety, Regulation and Case Processing
Paul Wang, Director, Pv Science, Gilead/Kite
Sep 1017:20
Conference pass

Chair’s remarks

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Haris Shaikh, Senior Director Pharmacovigilance, Orchard Therapeutics
Sep 1017:25
Conference pass

Signal management and PV models in small pharma

Signal Detection & Management and Safety in Medical Devices
Ashish Jain, Head of Pharmacovigilance, Curis Inc
Sep 1017:25
Conference pass

Risk management for established products and outsourcing functions

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Nicole Baker, EEA QPPV, Head of Global Pharmacovigilance, Besins Healthcare
Sep 1017:25
Conference pass

TBC

Big Data and AI in Safety, Regulation and Case Processing
Peter Verdru, Vice President and Head of Patient Safety, UCB Pharma ltd
Sep 1017:25
Conference pass

Safety measures in CAR T and Cellular Therapy

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
David Chonzi, VP, Patient Safety and Risk Management, Kite, A Gilead Company
Sep 1017:45
Conference pass

Impact of the new risk management requirements on PV systems for rare diseases

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Marco Sardella, Chief Pharmacovigilance Officer and Q.P.P.V. for Europe, Adienne
Sep 1018:05
Conference pass

Updating signal management processes in big pharma

Signal Detection & Management and Safety in Medical Devices
Yusuf Tanrikulu, Principal P.V. Process Leader, Roche
Sep 1018:05
Conference pass

Risk management in the lifecycle of a product

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Peter De Veene, QPPV, Alexion Pharmaceuticals
Sep 1018:05
Conference pass

PV in the world of gene therapy

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics

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Sep 1108:55
Conference pass

Chair’s opening remarks

Keynotes
Sep 1109:00
Conference pass

Post-Marketing Observational Studies for Pharmacovigilance in Asia: Opportunities, Issues and Management

Keynotes
Sep 1109:40
Conference pass

Database studies: Using electric medical records in Japan

Keynotes
Shinobu Uzu, Chief Safety Officer, Pharmaceuticals and Medical Devices Agency
Sep 1110:00
Conference pass

The pharmacovigilance landscape for low and middle-income countries: The Bill & Melinda Gates Foundation perspective

Keynotes
Raj Long, Deputy Director, Integrated Development, Global Health, The Bill & Melinda Gates Foundation
Sep 1111:10
Conference pass

Roundtables

Keynotes
Achieving effective safety standards during inspections
Lykke Bjerglund Graff, Head of Global Pharmacovigilance, LEO Pharma
Raj Bhogal, Regulatory Inspection Lead, Safety & International, R&D Quality Assurance & Compliance, Shire Pharmaceuticals
Achieving sustainability within an economic crisis
Dimitra Tsingreli, Qualified Person for Pharmacovigilance for Sigma, Kleva Pharmaceuticals Sa
Establishing PV agreements in emerging markets
Establishing PV quality management systems
Linda Helmfors, QPPV & Head of Pharmacovigilance, Bluefish Pharmaceuticals Group
Insights on PV systems across Russia and Eurasia
Vladimir Andrianov, Head of Scientific Studies Department, Institute of Interdisciplinary Medicine
Pharmacovigilance developments in Mexico
Rodrigo Ramirez, Head of Country Pharmacovigilance Mexico, Bristol-Myers Squibb
PV in the world of therapy allergens
Silvia Stoetter, Global PV Manager, Allergy Therapeutics
Andrea Maulwurf, Head of Pharmacovigilance, EU-QPPV, Allergy Therapeutics
Quantitative benefit-risk assessment: where are we today?
Risk minimization challenges and patient centricity
John Solomon, Head of Pharmacovigilance, Sanofi
The need for simplification in PV
Giovanni Furlan, Sr Director, EU QPPV, Seqirus
Sep 1113:20
Conference pass

Chair’s remarks

Signal Detection & Management and Safety in Medical Devices
Sep 1113:20
Conference pass

Chair’s remarks

Big Data and AI in Safety, Regulation and Case Processing
Tanja Peters, Deputy EU-QPPV Head PV Intelligence, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 1113:20
Conference pass

Chair’s remarks

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Jorgen Matz, Head of Global Pharmacovigilance and Drug Safety, Insud Pharma
Sep 1113:25
Conference pass

Risk management for medical devices

Signal Detection & Management and Safety in Medical Devices
Lisa Benaise, Global Head,Device Safety, Galderma
Sep 1113:25
Conference pass

The evolving landscape in safety for vaccines

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Pedro Lima, L.A.T.A.M. Regional Safety Lead, Sanofi
Sep 1113:25
Conference pass

MHRA Pharmacovigilance Inspection Programme: Priorities & Challenges

Big Data and AI in Safety, Regulation and Case Processing
Anna Adams, GPvP Inspector, MHRA
Sep 1113:25
Conference pass

Using RWE to support PV

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Sally Lee, Director of Pharmacodepidemiology EMEA / APAC, Celgene
Sep 1113:45
Conference pass

Real World Evidence (RWE) to support safety evaluation of vaccines

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
  • Brief overview of the global RWE landscape applying to vaccines & why vaccines are different when it comes to RWE generation
  • Recent experience with post-marketing safety evaluation of vaccines: challenges, opportunities and successes using selected examples
  • Future perspectives
Catherine Cohet, Director, Senior Epidemiology Expert, GlaxoSmithKline Vaccines
Sep 1113:45
Conference pass

Experiences from recent regulatory inspection

Big Data and AI in Safety, Regulation and Case Processing
Janie Willadsen, QPPV, LEO Pharma A/S
Sep 1114:05
Conference pass

One size does not fill all: Challenges that are encountered in a device centric organization

Signal Detection & Management and Safety in Medical Devices
Tauqeer Karim, Vice President of Drug and Device Safety Officer, Fresenius Medical Care North America
Sep 1114:05
Conference pass

Differences in the approach for assessing the safety profile of drugs and vaccines

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Maddalena Lino, Therapeutic Area Safety Head, Seqirus
Sep 1114:05
Conference pass

Pharmacovigilance and the role of regulatory affairs: How to achieve compliance across the business

Big Data and AI in Safety, Regulation and Case Processing
Jackie Roberts, Executive Director – Regulatory, Pharmacovigilance and Medical, Actavis
Sep 1114:05
Conference pass

RWE: Predictive Analytics to Impact Patient Safety

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
  • The use of new analytical tools applied to “big data” and gather real-time healthcare data are on the increase in the healthcare environment and have the potential to be of great value to make more informed and reliable strategic decisions earlier when it comes to protect patient safety.
  • Real-world evidence (RWE) offers great scientific and patient benefit as well as shortening phase III to accelerate the approval procedures.
  • This is mirrored by the need for pharmaceutical and biotech companies to quickly adapt their pharmacovigilance departments into cross-functional teams to confirm the expected benefit and value, often derived largely from controlled clinical studies.
Sep 1114:25
Conference pass

(No) Regulatory Drug Safety in Cell- and Tissue-based Therapies within Point-of-Care Settings

Signal Detection & Management and Safety in Medical Devices


Timo Faltus, Project Manager, University Halle Wittenberg Germany
Sep 1114:25
Conference pass

PV challenges for developing vaccines for rare diseases

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
  • Considerations about target populations, healthy vs. ill subjects
  • Benefit-risk assessment in low-incidence diseases
  • Ethical aspects for vaccine trials in special populations, such as paediatrics and elderly subjects
Sep 1114:25
Conference pass

Key updates on PRAC activities

Big Data and AI in Safety, Regulation and Case Processing
Doris Stenver, Chief Medical Officer, member of PRAC at EMA, Danish Medicines Agency
Sep 1114:25
Conference pass

Safety information pre-launch and post-launch: providing RWE for product safety

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets

Sep 1115:15
Conference pass

Chair’s remarks

Signal Detection & Management and Safety in Medical Devices
Sep 1115:15
Conference pass

Chair’s remarks

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Syed Zaferuddin, Deputy QPPV, Jamjoom Pharmaceuticals
Sep 1115:20
Conference pass

Drug safety in children

Signal Detection & Management and Safety in Medical Devices
  • Specificities to take into account when performing signal detection in children
  • Importance of data entry on the results of signal detection
  • Importance of the disease
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 1115:20
Conference pass

Evaluating the clinical safety of a biosimilar: totality different and/or exactly the same?

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
  • The “Totality of evidence”: integrating evidence across domains
  • A Bayesian perspective on the clinical safety of candidate biosimilars
  • Reflecting on residual uncertainty: the tension between a medico-scientific and a legal perspective
Uwe Gudat, Head of Safety, Biosimilars, Fresenius Kabi
Sep 1115:20
Conference pass

AI in case processing

Big Data and AI in Safety, Regulation and Case Processing
Diane Beck, Vice President, Head of Pharmacovigilance Services, Takeda Pharmaceutical Company
Sep 1115:20
Conference pass

Implementation of a PV support model in China

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Richard Wolf, Head of I.C.S.R. Case Management and Evaluation Regions and Pv Systems, C.S.L. Behring Gmbh
Kevin Burke, Senior Case Management Lead, CSL Behring
Elva Xu, Associate Director, Medical Affairs and Pharmacovigilance, CSL Behring
Kevin Tynan, Consultant, Pv Operations Global Clinical Safety and Pharmacovigilance, CSL Behring
Sep 1115:40
Conference pass

What happens when pharmacovigilance fails? A Norwegian story

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway
Sep 1115:40
Conference pass

The changing PV landscape: Harmonization and “right-size” PV in emerging markets

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Jabeen Ahmad, Regional Pharmacovigilance Director, EEMEA, Affiliate Vigilance Excellence, AbbVie
Sep 1116:00
Conference pass

Signal detection and risk management in generics

Signal Detection & Management and Safety in Medical Devices
Avinash Kakade, Senior Director and Head of Pharmacovigilance, Cipla
Sep 1116:00
Conference pass

Traceability of biologics and impact of safety signal detection

Risk Management/ Benefit-risk Management, Vaccine Safety and Drug Safety in Biosimilars & Biologics
Pieter Stolk, Programme Manager, Lygature
Sep 1116:00
Conference pass

Enhanced EudraVigiliance system – industry perspectives

Big Data and AI in Safety, Regulation and Case Processing
Sep 1116:00
Conference pass

PV developments in Saudi Arabia and the Middle East

Safety in Oncology, PV Outsourcing, Real World Evidence in PV and PV in Emerging Markets
Syed Zaferuddin, Deputy QPPV, Jamjoom Pharmaceuticals
last published: 13/Jun/18 10:25 GMT