DRUG SAFETY CONGRESS EUROPE 2021 AGENDA

Amsterdam, 6 - 7 October 2021

Schedule

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Oct 608:55
Conference pass

Chair’s remarks

Keynotes
Felix Arellano, Global Head Safety Risk Management, F.Hoffmann-La Roche
Oct 609:20
Conference pass

Keynote Panel Discussion: Is it time to revisit our traditional approach to safety data gathering pre- and post-approval?

Keynotes
Felix Arellano, Global Head Safety Risk Management, F.Hoffmann-La Roche
Deepa Venkataraman, Head of Global Patient Safety and Pharmacovigilance, Summit Therapeutics
Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen
Sumit Munjal, Vice President, EU QPPV and UK QPPV, Takeda
Phil Tregunno, Group Manager, Vigilance, Intelligence And Research, Medicines & Healthcare Products Regulatory Agency
Raj Long, Deputy Director, Integrated Development, Global Health, Bill and Melinda Gates Foundation
Liana Gross Martirosyan, Alternate Member, PRAC Committee
Oct 611:20
Conference pass

Chair remarks

AI + AUTOMATION
Kieran O'Donnell, Principal Consultant, Arriello
Oct 611:20
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Chair remarks

RISK MANAGEMENT
Rudi Scheerlinck, Pharmacovigilance Risk Management Clinical Studies, Galderma
Oct 611:20
Conference pass

Chair remarks

SIGNAL DETECTION & MANAGEMENT
Mark Perrott, Managing Partner, Axian Consulting ltd.
Oct 611:20
Conference pass

Chair remarks

QUALITY ASSURANCE AND COMPLIANCE
Magda Daudin, Director, Pharmacovigilance QA Lead, Idorsia
Oct 611:25
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Drug safety in elderly patients

RISK MANAGEMENT
Giovanni Furlan, Safety Risk Lead Director, Pfizer
Oct 611:25
Conference pass

The broad interfaces of PV with GXPs: Achieving the right standard

QUALITY ASSURANCE AND COMPLIANCE
Ranjana Khanna, Director, Head Of Pv Quality Assurance, Vifor pharma
Oct 611:45
Conference pass

Quality. Cost. Speed. What really matters for PV automation adoption

AI + AUTOMATION
Natalia Vlcek, EU QPPV, Arriello
Oct 611:45
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Implementation of complex risk minimisation measures

RISK MANAGEMENT
Jackie Roberts, Associate Vice President, Scientific Affairs, Governance, Accord Healthcare
Oct 611:45
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Best practice in signal management across product life cycle

SIGNAL DETECTION & MANAGEMENT
Oleksandr Karpenko, Managing Director, Principal Consultant, Olexacon Ltd
Oct 612:05
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The impact of AI on PV systems

AI + AUTOMATION
Mircea Ciuca, TA Head, CSL Behring
Oct 612:05
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Tailored approaches towards benefit-risk evaluations

RISK MANAGEMENT
Tjark Reblin, Global Head Drug Safety and Risk Management, Vifor pharma
Oct 612:05
Conference pass

New age signal detection: Harnessing real world evidence integrated technologies

SIGNAL DETECTION & MANAGEMENT
Siva Kumar Buddha, Global Safety Physician Manager Product Safety and Risk Management, Viatris- Mylan
Oct 612:05
Conference pass

Developing COVID treatment in the midst of the pandemic: Protecting patients and pharmacovigilance compliance in extraordinary circumstances

QUALITY ASSURANCE AND COMPLIANCE
Eva Van Engelen, Associate Director Global Patient Safety, Gilead Sciences
Oct 612:25
Conference pass

Leverage automation to surface safety signals more quickly and efficiently

AI + AUTOMATION
Andrew Rut, Chief Executive Officer And Founder, MyMeds&Me
Oct 612:25
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Lessons learned from the first phase implementation of a digital risk management platform

RISK MANAGEMENT
Mariette Boerstoel-Streefland, SVP Patient Safety, Chief Safety Officer, AstraZeneca
Oct 613:55
Conference pass

Roundtables

Keynotes
Roundtable 17: The use of digital tools to achieve risk management objectives
Mark Perrott, Managing Partner, Axian Consulting ltd.
Roundtable 20: Adapting PV audit practices in a pandemic
Sharon Fabrizio, Head of Local PV Quality Oversight - Global Scope, Sanofi
Roundtable 22: Quality. Cost. Speed - Discussing the results from Arriello’s brand new transatlantic PV automation adoption survey
Kieran O'Donnell, Principal Consultant, Arriello
Natalia Vlcek, EU QPPV, Arriello
Roundtable 2: Exploring medicines safety in maternal health
Belen Granell Villen, Quality And Safety Policy Executive, ABPI
Roundtable 4: Achieving best practice in on-site and remote inspections
Laura Paola Boga, Head of Global Pharmacovigilance & EU Qualified Person for Pharmacovigilance, Dompé Farmaceutici SPA
Roundtable 6: How does the UK PSMF comply with other territory PSMF requirements?
Monika Manske, Lead Quality Management and Deputy EEA QPPV, PSRM, Pharmacovigilance Safety & Risk Management, Viatris
Roundtable 7: How to manage different QPPV roles and responsibilities to meet local requirements?
Valentina Mancini, EU QPPV, Shionogi Pharma
Roundtable 9: Meeting the requirements of case submission oversight from health authorities and business partners
Melanie Dullemond, PVQ Compliance Head, Sanofi
Oct 614:50
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Chair remarks

AI + AUTOMATION
Kieran O'Donnell, Principal Consultant, Arriello
Oct 614:50
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Chair remarks

RISK MANAGEMENT
Amgad Shebl, Director, Global Clinical Safety And Pharmacovigilance, CSL Behring
Oct 614:50
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Chair's remarks

SIGNAL DETECTION & MANAGEMENT
Katrien Soleme, Senior Director, Pharmacovigilance and Life Cycle Management Quality, Bristol Myers Squibb
Oct 614:50
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Chair remarks

QUALITY ASSURANCE AND COMPLIANCE
Mina G Awad, Pharmacovigilance Manager and QPPV, Middle East., Kyowa Kirin International
Oct 614:55
Conference pass

Risk communication in Non-EU countries

RISK MANAGEMENT
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Oct 614:55
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Intelligence analysis in safety assessments

SIGNAL DETECTION & MANAGEMENT
Max Waschbusch, TA Head Cardiovascular and Metabolism, CSL Behring
Oct 615:15
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Artificial Intelligence models to identify Adverse Events and Special Situations in the global and local scientific literature

AI + AUTOMATION
Bruno Ohana, CTO, biologit
Oct 615:35
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NLP-based AI for safety applications in Pharma

AI + AUTOMATION
Jane Reed, Director, Life Sciences, Linguamatics
Oct 615:35
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PMSR for combination products in the US and its global impact

RISK MANAGEMENT
Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen
Oct 615:35
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Understanding the challenges from signal validation to the timely implementation of reference safety information

SIGNAL DETECTION & MANAGEMENT
Katrien Soleme, Senior Director, Pharmacovigilance and Life Cycle Management Quality, Bristol Myers Squibb
Oct 615:35
Conference pass

Developing a global safety intelligence process

QUALITY ASSURANCE AND COMPLIANCE
Heike Von Treichel, Head Of Qualified Person For Pharmacovigilance Office, Merck
Oct 616:25
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Chair remarks

AI + AUTOMATION
Andrea Maulwurf, Head of Corporate Pharmacovigilance, Global Leading Qppv, Allergy Therapeutics
Oct 616:25
Conference pass

Chair remarks

RISK MANAGEMENT
Valentina Mancini, EU QPPV, Shionogi Pharma
Oct 616:25
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Chair remarks

SIGNAL DETECTION & MANAGEMENT
Colleen Moody, Senior Manager, Safety Risk Management Scientist, United Therapeutics
Oct 616:25
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Chair remarks

VACCINE SAFETY & PV SYSTEMS
Deborah Layton, Director of Epidemiology, Global Database Studies, Real World Solutions, IQVIA
Oct 616:30
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The use of robotic automation in PV

AI + AUTOMATION
Manoj Swaminathan, Founder, VigiServe Foundation
Oct 616:30
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Are we really managing risks or just administrating the risks?

RISK MANAGEMENT
Uwe Gudat, Head Of Clinical Safety And Pharmacovigilance Clinical Safety And Pharmacovigilance, Fresenius Kabi SwissBiosim
Oct 616:30
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Our transformation journey: From compliance driven to proactive safety surveillance

SIGNAL DETECTION & MANAGEMENT
Markus Krupp, Associate Director, Safety Signal Management & Data Analytics, Merck Healthcare KGaA
Oct 616:30
Conference pass

Monitoring the safety of the COVID-19 Vaccines using open source technology

VACCINE SAFETY & PV SYSTEMS
Lionel Van Holle, Safety Surveillance Lead, UCB
Oct 616:50
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Considerations in deploying AI-enabled digital ICSR into production

AI + AUTOMATION
Vladimir Penkrat, Associate Vice President - Global Head of Safety & Regulatory Affairs, Indegene Inc.
Oct 616:50
Conference pass

What is the impact of post-authorisation safety studies on benefit-risk balance for medicines?

RISK MANAGEMENT
Liana Gross Martirosyan, Alternate Member, PRAC Committee
Oct 616:50
Conference pass

Building a global centralized PV system from multiple independent PV system

VACCINE SAFETY & PV SYSTEMS
Margherita D'Antuono, E.U. Q.P.P.V., ITALFARMACO S.P.A.
Oct 617:10
Conference pass

Utilising social media to support signal detection

AI + AUTOMATION
Juhaeri Juhaeri, VP & Head, Epidemiology and Benefit-Risk, Sanofi
Oct 617:10
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Cross-functional benefit risk strategy, management and documentation

RISK MANAGEMENT
Elian Khazneh, Head of Medical Safety Operations, Merck Healthcare KGaA
Oct 617:10
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Harnessing AI to enhance signal detection capabilities

SIGNAL DETECTION & MANAGEMENT
Anupam Agarwal, Vice President Global Head Of Drug Safety And Pv, Zogenix

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Oct 708:55
Conference pass

Chair’s remarks

Keynotes
Mariette Boerstoel-Streefland, SVP Patient Safety, Chief Safety Officer, AstraZeneca
Oct 709:00
Conference pass

Ibuprofen Safety: The Covid-19 Story

Keynotes
Simon Sinclair, Chief Safety Officer, Reckitt Benckiser plc
Oct 709:40
Conference pass

Key developments in Chinese PV Regulation and how to be a compliant affiliate

Keynotes
Gloria Bustos, Head Of Pharmacovigilance Emea And Apac, Baxter Corp
Oct 710:00
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The strategic role of Affiliate Patient Safety in patient-centricity: Our journey

Keynotes
Christina Bisschops-Kaltenbach, Global Head International Pharmacovigilance, Safety Risk Management, F. Hoffmann-La Roche Ltd
Oct 711:20
Conference pass

Chair remarks

CASE PROCESSING
Deanna Montes De Oca, Sr.Director, PV Operations-Global Case Management, Moderna Therapeutics
Oct 711:20
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Chair remarks

TRANSLATIONAL SAFETY
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 711:20
Conference pass

Chair remarks

PV OUTSOURCING
Martijn van de Leur, Head of Global Pharmacovigilance, Biomapas
Oct 711:20
Conference pass

Chair remarks

EMERGING MARKETS
Sutirtha Mukhopadhyay, Senior Risk Management Physician, Boehringer Ingelheim
Oct 711:25
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How to perform effective safety reviews for case assessment

CASE PROCESSING
Daniela Di Cosmo, Senior Pharmacovigilance Manager, Global Pharmacovigilance, Ferring Pharmaceuticals
Oct 711:25
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Patient-centric approach to translational safety

TRANSLATIONAL SAFETY
Scott Chandler, Global Head, Personalized Health Care (PHC) Safety, F. Hoffmann - La Roche
Oct 711:25
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Speaker presentation

EMERGING MARKETS
Tarik Messaoud, Drug Safety Physician, Independent
Oct 711:45
Conference pass

Examining the impact of Brexit on Pharmacovigilance activities

CASE PROCESSING
Carmela Campana, Pharmacovigilance Manager and EU QPPV, Istituto Biochimico Italiano G. Lorenzini S.p.A.
Oct 711:45
Conference pass

Leveraging data from FDA/EMA drugs to support translational safety analytics: Developing an industry validated methodology for target safety risk assessment

TRANSLATIONAL SAFETY
Catherine Noban, Lead Product Manager – Content Assets, Elsevier
Oct 711:45
Conference pass

Local Safety Representatives Challenges What is the 1st line Safety person facing?

EMERGING MARKETS
Mohamed Abdel-Hady, Sr. Manager, Global Patient Safety UAE, Gilead Sciences
Oct 712:05
Conference pass

Speaker presentation

PV OUTSOURCING
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Oct 712:05
Conference pass

Exploring the regulatory landscape in Saudi Arabia, Oman, Egypt and UAE

EMERGING MARKETS
Syed Zaferuddin, Global Pharmacovigilance Manager and QPPV, Julphar
Oct 712:25
Conference pass

Pharmacovigilance Outsourcing – A trend and advantages with regulatory compliance

PV OUTSOURCING
Prashanth Bsb, Director PV & QPPV, Product life Group
Oct 713:55
Conference pass

Roundtables

Keynotes
Roundtable 13: Exploring literature surveillance tools and processes
Paolo Voltolina, Director, Head of Regulatory Business Operations, Lundbeck
Roundtable 14: Switching from a de-centralised to centralised affiliate model in Europe: Considerations from mid-pharma
Albert Befki, Head of Pharmacovigilance Operations, Biomapas
Attila Olah, Head Global Pharmacovigilance, Eu-Qppv, Gedeon Richter PLC
Roundtable 15: Early detection of safety signals in clinical trials
Sutirtha Mukhopadhyay, Senior Risk Management Physician, Boehringer Ingelheim
Roundtable 16: Highlighting the importance of ADRs in the Middle East and ensuring compliance at all levels
Muhammad Ashar Naeem, Global Director and head of Pharmacovigilance and Medical Affairs Department, Jamjoom Pharma
Roundtable 17: Exploring the challenges with R3 reporting standards in different countries and what are the potential solutions?
Andrea Maulwurf, Head of Corporate Pharmacovigilance, Global Leading Qppv, Allergy Therapeutics
Roundtable 5: Medication safety: New Era of best practice
Fatima Ghethan, Head of Quality and Medication Safety Unit, KAMC
Alaa Yousef Ghidan, Doctor, The Higher Council For Science And Technology
Roundtable 6: Exploring the role of Real-World Data in pharmacovigilance
Hadir Rostom, president, ISoP Egypt Chapter
Roundtable 8: Ensuring patient safety and data privacy within de-centralised trials
Vivienne Van De Walle, Medical Director, P.T. and R
Roundtable 9: Exploring the critical paths of device safety in clinical investigations
Sylvie Bartus, Head of Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
Oct 714:55
Conference pass

Chair remarks

CASE PROCESSING
Ellen Ravn Englev, Senior Director, Case Management department, Safety Operations, Global Safety, Novo Nordisk
Oct 714:55
Conference pass

Chair remarks

MEDICAL DEVICES
Sylvie Bartus, Head of Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
Oct 714:55
Conference pass

Chair remarks

PATIENT ADVOCACY & CENTRICITY
Ann Chivers, Chief Executive, Alstrom Syndrome U.K.
Oct 715:00
Conference pass

Opportunities of Digital Health for Patient Safety

MEDICAL DEVICES
James Whitehead, Patient Safety Medical Device Lead, Astra zeneca
Oct 715:00
Conference pass

Fighting the fakes: Ensuring drug safety during a Pandemic

PATIENT ADVOCACY & CENTRICITY
Mary Lynne Van Poelgeest-Pomfret, President, President of the World Federation for Incontinence and Pelvic Pain - WFIP
Oct 715:20
Conference pass

Common mistakes in case processing and useful tips to avoid them

CASE PROCESSING
Aitzaz Khan, Global Safety Lead, Argenx
Oct 715:20
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How can pharma improve healthcare for the patient: What does patient centricity really mean?

PATIENT ADVOCACY & CENTRICITY
Kristof Vanfraechem, CEO, Data For Patients
Christine Von Raesfeld, Founder, People with Empathy
Oct 715:20
Conference pass

Optimising early clinical investigations in cancer immunotherapy by increasing the translational value of non-clinical activities

SAFETY IN ONCOLOGY
Estelle Marrer-Berger, Toxicology Project Leader, Roche
Oct 715:40
Conference pass

Experiences using machine translation to support global case in-take

CASE PROCESSING
Adrian Maynier, Head of Safety Systems, UCB
Oct 715:40
Conference pass

Adverse events and device deficiencies from medical device studies: Sponsor safety assessments and independent adjudication

MEDICAL DEVICES
Talia Milosevic, Manager, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
Oct 715:40
Conference pass

Biosimilar safety in the world of oncology

SAFETY IN ONCOLOGY
Andrea Oliva, Head of Pharmacovigilance, Italy Product Safety & Risk Management, Viatris
Oct 716:00
Conference pass

What would personalised safety, delivered in a patient centric way, look like from a patient's perspective

PATIENT ADVOCACY & CENTRICITY
Jacquelien Noordhoek, President, CF europe
last published: 17/Sep/21 16:15 GMT

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