Prominent Speakers

ü

ü

ü

ü

Alistair J. Coates – Director - EudraVigilance Consultants Ltd.

Paul Dolin, Senior Director Pharmacoepidemiology, Takeda UK Ltd

ü Luiz Lima, Pharmacovigilance Country Head, Bayer

ü Jacqueline Roberts, Director - Regulatory, PHV and Medical, Actavis

ü Sumit Munjal, MD Global Pharmacovigilance, Takeda Pharmaceuticals

ü Deborah Layton, Principal Research Fellow, DSRU

ü Rachel Spokes, Deputy EU QPPV, Global Safety & Epidemiology, Allergan

ü Arlene Gallagher, Statistician, Epidemiologist Clinical Practice Research Datalink, MRHA

ü Pipasha Biswas, Director & QPPV, Symogen

ü Sandip Chaudari, Senior Director Clinical Safety and Risk Management, Pfizer

ü Doris I. Stenver, Chief Medical Officer, Danish Health and Medicines Authority

Nawab Qizilbash, Clinical Epidemiologist & Head, OXON Epidemiology

Antoni Wisniewski – Systems Area Lead, Patient Safety Analytics, AstraZeneca

Pharmacovigilance 2014

th th18 & 19 November 2014, Hilton Euston, London, UK

"Effectively managing and identifying potential risks regarding drug safety"

th th18 & 19 November 2014, London, UK

Gold Sponsor

Associate Sponsor

EudraVigilance Consultants Ltd

PLD Sponsor

Expected Attendees

VPs, Directors, Heads, Managers, Scientific, Advisors, Consultants of:

ü Pharmacovigilance

ü Pharmacoepidemiology

ü Pharmacogenomics, Drug/Product Safety

ü Drug Development, Information and Clinical Data Management

ü Clinical Pharmacology

ü Clinical Safety

ü Periodical safety update Reports

ü Risk Management, Research & Development

ü Quality Assurance

ü Patient Safety

ü Signal Detection

ü Safety Surveillance

ü Outcomes Research

ü Data Analysis

ü Epidemiology

ü Medical Affairs

ü Regulatory Affairs and Compliance

ü Information technology

ü Sales and Marketing

Industry Sectors:

ü Pharma

ü Biotechnology

ü CROs

ü Software Providers

th th18 & 19 November 2014, London, UK

Key Themes

ü Design risk-benefit analysis tools to enhance internal risk evaluation and mitigation strategies.

ü Review the current European Union regulations

ü Examine global drug safety; Pharmacovigilance strategies

ü Understand the use of social media in Pharmacovigilance

ü Learn about effective signal detection strategies

ü Gain insight into safety of Medical Devices

Day Oneth18 November 2014

08:30

09:30 Chairperson’s opening remarks:

Paul Dolin - Senior Director Pharmacoepidemiology,

Takeda UK Ltd

09:40 - 10:10 Opening Address:

Evolving Pharmacovigilance and Commercial Strategies

ŸCollaboration- How PV teams collaborate more

effectively with key external stakeholders to drive

better outcomes?

ŸGlobalization- How will organizations operate more

effectively across multiple regions and health

authorities?

ŸTransparency and Trust- approach for driving higher

levels of internal and external transparency by

ensuring that safety information reaches the right

audience.

ŸSupportive Function- Back office to Front Office.

10:10 - 10:40

Business Strategy for Risk Management Plans – local

issues and solutions

ŸCase studies on how risk minimization measures can be

effectively introduced and monitored.

ŸHow to ensure your Risk Management programme is

inspection ready.

ŸCross-functional and international co-operation in the

management of risk.

Jacqueline Roberts - Director Regulatory, PHV and

Medical, Actavis.

10:40 - 11:10

Pharmacovigilance Safety Case Management

ŸDesigning and implementing short-term and long-term

case processing needs.

ŸAdverse event processing.

11:10 - 11:30

Coffee and Registration

Coffee Break and Speed Networking

Commercial Strategies

11:30 - 12:00

Evaluating Risk Management Tools in Pharmacovigilance

ŸInteractive web-based tools.

ŸPaper-based information and educational materials.

Luiz Lima - Pharmacovigilance Country Head, Bayer

12:00 - 12:30

Risk Minimization

ŸExpectations from regulator.

Ÿ Development of additional risk minimization measures.

ŸEvaluation of additional risk minimization measures.

Nawab Qizilbash - Clinical Epidemiologist and Head,

OXON Epidemiology

12:30 - 13:00

A Researcher's perspective of Risk Management Planning

ŸFulfilling the need for innovation.

ŸUnderstanding the local health services in practice.

ŸStudy design considerations.

ŸReal-life case examples.

Deborah Layton - Principal Research Fellow, DSRU

13:00 - 14:00

14:00 - 14:30

Update on Good Pharmacovigilance Practice (GVP)

Guidelines

ŸInformation on the latest modules being approved in

November 2014?

ŸBiological Medicinal Models Product or population

specific considerations.

Doris I. Stenver - Chief Medical Officer, Danish Health and

Medicines Authority

Networking Lunch

Regulation Overview

Risk Management and Planning

Day Oneth18 November 2014

14:30 - 15:00

The importance of the Pharmacovigilance System Master

File (PSMF)

ŸPSMF Deadlines.

ŸWhat will be the content of PSMF?

ŸHow to make changes to the master file?

ŸTraining requirements for employees.

Rachel Spokes - Deputy EU QPPV / Senior Safety Scientist

Global Safety & Epidemiology, Allergan

15:00 - 15:20

15:20 - 16:00

Panel Discussion: Experience of the new EU regulations

is harmonization a vision of the future?

ŸDirect patient reporting in all EU member states.

ŸHow will harmonization take place and is it

necessary?

ŸHow will companies tackle the new fees that are

being implemented?

ŸWhat are the rules for new product approval?

ŸLessons Learnt.

16:00 - 16:30

Impact of Social Media on Pharmacovigilance and Drug

Safety

ŸSocial networking

ŸPatient networking

ŸWebsites

16:30 - 17:00

Explore latest IT Platforms leveraging the Cloud,

Analytics and Mobile Computing.

17:00 - 17:10

Chairperson’s closing remarks and end of conference

17:10 - 18:10

Afternoon Tea

Networking Drinks Reception

Technology Impact

08:30

09:20 Chairperson’s opening remarks

09:30 - 10:00 Signal Detection Activation

ŸSignal-detection algorithms (SDAs) vital tools in

Pharmacovigilance.

ŸChoosing right method for signal detection Quantitative

or Qualitative or manual or automated.

ŸChallenges in signal management.

Antoni Wisniewski - Systems Area Lead, Patient Safety

Analytics, AstraZeneca

10:00 - 10:40

Panel Discussion: Latest Technologies in Signal Detection-

Large and Small Pharma

ŸWhat are the types of signal detection technologies?

ŸDifferences between what is used for small and large

Pharmaceutical companies.

ŸDrawbacks of the technologies-Improvements required.

Pipasha Biswas - Director & QPPV, Symogen Limited

Sumit Munjal - Medical Director, Takeda

10:40 - 11:20

Automated Signal Detection Services -Better analyse and

understand data from clinical studies

11:20 - 11:40

11:40 - 12:10

Implementation of Post Marketing Safety Surveillance of

Products

12:10 - 12:40

Adverse Reaction Reporting from Medical Devices

12:40 - 13:40

13:40 - 14:10

Innovation and Performance of Medical Devices in EU.

Coffee and Registration

Coffee Break

Networking Lunch

Medical Devices

14:10 - 14:40 Safety of Medical Devices

ŸMedical device safety regulations.

ŸChallenges in safety of Medical devices.

ŸMeddev & Incident reporting in Medical devices.

ŸThe future of safety of Medical Devices.

Pipasha Biswas - Director & QPPV, Symogen Limited

14:40 - 15:10

Panel Discussion: How to Update Database for Medical

Products( EudraVigilance)?

ŸWhat is the procedure?

ŸChallenges and difficulties.

ŸCompanies share experiences.

Alistair J. Coates – Director - EudraVigilance Consultants

Ltd.

15:10 - 15:30

15:30 - 16:00

Using Real World Evidence in Pharmacovigilance and

Drug Safety

Arlene Gallagher - Senior Researcher, Medicines and

Healthcare Products Regulatory Agency

16:00 - 16:30

Provision of Medicines Safety Signal and Benefit Risk

Information: Impact of the new Pharmacovigilance

legislation.

Sandip Chaudhari - Senior Director and Clinical Safety and

Risk Management Lead, Pfizer

16:30 - 17:10 Update on when ADR reports is exchanged during

Clinical Trials

ŸADR from EU companies clinical trials.

ŸDrug is non-investigational medicinal product.

ŸClinical trials from outside EU.

17:10 - 17:20

Chairperson’s closing remarks and end of conference

Reports and Database

Afternoon Tea

Day Twoth19 November 2014

Safety and Signal Detection

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