19th Pharmacovigilance 2019

19th Pharmacovigilance 2019

WHY SHOULD YOU ATTEND?

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

Event Speakers

COLLEEN WALSH

Alexion Pharmaceuticals

SANDRA RAFF

Novartis

MELVIN M

Abbvie

XIAO NI

Novartis

WILLIAM B

Sanofi Genzyme

KINJAL PATEL

Bristol-Myers Squibb

HARISHA K

Takeda Pharmaceuticals

NATALIA H

AB Cube

RICHARD WOLF

CSL Behring

PHIL TREGUNNO

MHRA (UK)

STEINAR M

Norwegian Medicines Agency

TOYIN ADEWOLE

Supernus Pharmaceuticals

MIRCEA CIUCA

CSL Behring (Switzerland)

RICKY R

Takeda Oncology

FARIDA ABANE

Deciphera Pharmaceuticals

SANJEEV M

AWINSA Life Sciences

HEATHER L F

ConsenSys Health

MUGDHA CHOPRA

AWINSA Life Sciences

KATE GOFMAN

Astrazeneca

KEVIN TYNAN

CSL Behring

DAVID H

Brookwood International Academy

MELVA C

EVERSANA

BEN LOCWIN

Lumicell

“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”

Event Schedule

Meet and to network with your conference colleagues.

08:30 – Coffee and Registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks

BEN LOCWIN, Senior Vice President, Quality, Lumicell

PRE-CLINICAL & CLINICAL TRAILS

09:40 – Investigations relating to Clinical Trial Fraud

•   Overview of FDA OCI
•   Blue Print of a Clinic Trial Fraud Investigation
•   Case Example of Clinic Trial Fraud Investigation

DEREK ROY, Resident Agent in Charge, FDA

OUTSOURCING

10:20 – Outsourcing activities - Choosing your right vendor and setting the path right

•   How to select the right vendor for outsourcing pharmacovigilance activities?
•   Setting up an efficient communication channel between Sponsor and Vendor
•   Sponsor expectations: delivering pharmacovigilance support and service at the highest levels of quality and satisfaction ensuring patient safety and compliance
•   What are the challenges encountered for both Sponsor and Vendor?

FARIDA ABANE, Associate Medical Director Pharmacovigilance, Deciphera Pharmaceuticals

10:50 – Morning Coffee / Tea & Discussion

11:10 – Safety Visual Analytics and its Application

XIAO NI, Director, Scientific Computing and Consulting, Novartis

CHALLENGES & OPPORTUNITIES

11:40 – Keynote Panel Discussion: Challenges and Opportunties for Effective Pharmacovigilance in the 21st Century

•   Challenges and Opportunities for effective Pharmacovigilance in the 21st Century
•   Update on PV in EU, USA & RoW - Current and new trends for PV, and future guidelines
•   Globalization of Pharmacovigilance
•   Creating a proactive drug safety culture
•   Where is the market heading and what needs to be done?
•   Strategies to stay ahead of the curve
•   Pharmacovigilance - The effect of Brexit

Moderator
BEN LOCWIN, Senior Vice President, Quality, Lumicell

Panellists
WILLIAM BLUMENTALS, Sr. Director, Head of Pharmacoepidemiology, Sanofi Genzyme
COLLEEN WALSH, Senior Director, Pharmacovigilance & Regulatory Quality Management Operations, Alexion Pharmaceuticals
RICHARD WOLF, Executive Director, Pv Operations, CSL Behring
TOYIN ADEWOLE, Associate Director, Drug Safety - Clinical Research, Supernus Pharmaceuticals
MELVA COVINGTON, Senior Director, EVERSANA

12:20 - The passage from E2BR2 to R3

•   The repercussions on the Pharmacovigilance database and on the end user.
•   A case study in the successful transition process

NATALIA HOLMAN, Business Developer, AB Cube

12:50 – Networking luncheon

14:10 – Special considerations for pediatric population in Pharmacovigilance (GVP chapter IV).

HARISHA KADALI, Associate MedicalDirector, Takeda Pharmaceuticals

SIGNAL DETECTION

14:50 – Signal detection & management

•   Methods on signal detections
•   Challenges of signal detection in spontaneous reporting
•   Aligning expectations between industry and regulators on signal detection and investigation
•   How to monitor safety in blinded clinical trials?
•   Statistical approaches to looking at blinded data and detecting signals
•   Signal Detection: Innovations and challenges

MIRCEA CIUCA, Global Head Medical & Clinical Drug Safety, Vifor Pharma (UK)

15:20 - Afternoon Tea / Coffee

15:40 – The EU General Data Protection Regulation and its impact on trials and safety data collection Topic TBC

•   The scope of the GDPR.
•   How and when non-EU trials are affected
•   5 key things to ensure compliance
•   Interplay with other regulations

16:10 - Surprise Fun Activity

16:40 - Chairperson’s closing remarks and end of conference

16:40 - 18:00 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting

08:30 – Coffee and Registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks

BEN LOCWIN, Senior Vice President, Quality, Lumicell

MOBILE & AI IN PV

09:40 – Morning Keynote Address 1 – Use of mobile applications and AI in Pharmacovigilance

•   Opportunities to exploit the use of mobile technology
•   An update from the Innovative Medicines Initiative WEB-RADR Project
•   Regulatory expectations for the use of AI
•   Requirements to move AI pilots to production

PHIL TREGUNNO, Group Manager - Vigilance, Intelligence and Research Group, MHRA (UK)

PV AUDIT & INSPECTIONS

10:10 – PV Audit & Inspections - Preparation, implementation and lessons to be learnt

•   Major and a vital role - Monitoring PV compliance
•   PV Inspection readiness: What to expect? How ready can we be?
•   PV Compliance: PV is at the Center but cannot do it alone. How to mobilize internal and external stakeholders?
•   Risk based selection criteria for auditing
•   Methodologies, scope and oversight
•   Relationship to other GxPs

BRUNO MENDEZ, VP Global Quality Head Pharmacovigilance, Sanofi

SAFETY

10:40 – Safety reporting requirements in Global clinical trials: Regulations demystified

MUGDHA CHOPRA, Cofounder & Directorv, AWINSA Life Sciences

10:55 – Safety Management in Global Clinical trials: Unraveling the enigma

SANJEEV MIGLANI, Founder and Director, AWINSA Life Sciences

11:10 – Morning Coffee / Tea & Discussion

IMPACT OF TECHNOLOGY

11:30 - Blockchain and the Advancement of Pharmacoviglance (PV)

•   The big picture of blockchain in healthcare and life sciences
•   Benefits and risks of utilizing blockchain for PV and Real-World Evidence
•   Blockchain-based PV program through the lens of each stakeholder group
•   Real-world initiatives and consortia piloting these capabilities
•   Bioethics of blockchain, advanced privacy preserving technologies, and PV
•   Steps to assessing whether and how to use blockchain in your PV program

HEATHER LEIGH FLANNERY, Global Lead, ConsenSys Health

PV - RISK MANAGEMENT & PLANNING

12:10 – Panel Discussion - Evaluating risk management requirements – What and how to do?

•   Risk management development: Making the best out of it
•   How to put Benefit-risk assessments into practice?
•   How to write a successful risk management plan?
•   Including the patient in the benefit: risk assessment at an early stage in drug development?
•   Improving risk:benefit assessment with comprehensive data and a quality, compliant safety system
•   How to strengthen your organization by leveraging your safety platform?
•   Periodic Benefit-Risk Evaluation Report
•   Working together - Managing communications between - Sponsor – Site – CRO & Patients

Moderator
GERSON PELTZ, Senior Director - Oncology Safety Risk Lead, Pfizer

Panellists
SANDRA RAFF, Senior Director, Global Safety Lead, Novartis
SHARON REID, Director, Risk Management Product Lead, Pfizer
KINJAL PATEL, Global Safety and Risk Management Implementation Manager, Bristol-Myers Squibb
MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and Phamacovigilance, CSL Behring (Switzerland)

12:50 - Networking luncheon

13:50 – Why does pharmacovigilance sometimes fail and where could the fault lie?

•   Risk blindness - industry or drug authorities?
•   It’s not my fault – but whom to blame?
•   Hard to detect adverse reactions
•   Do we learn from previous experiences?

STEINAR MADSEN, Medical Director, Norwegian Medicines Agency (UK)

SAFETY

14:20 - Panel Discussion: Safety - Growing companies and safety efficiencies

•   The future of signal detection
•   Maximizing safety efficiency – Building safety programs of scale and implementing them across company locations
•   Developing signal detection capabilities in real world data
•   Statistical methods for signal management
•   Role of local safety officers in evolving pv market
•   Improving safety and lowering cost
•   Using technology as intricate part of modern pv

Moderator
BEN LOCWIN, Senior Vice President, Quality, Lumicell


Panellists
RICKY RUDRARAJU, Sr. Principal Scientist - Global Patient Safety Evaluation, Takeda Oncology
KEVIN TYNAN, Consultant, Global Clinical Safety and Pharmacovigilance, CSL Behring
STEINAR MADSEN, Medical Director, Norwegian Medicines Agency (UK)

15:00 – Safety/ Benefit Risk Assessment Planning and Visualization

WILLIAM WANG, Executive Director, Clinical Safety Statistics, Merck
MELVIN MUNSAKA, Senior Director Head Safety Statistics, Abbvie

15:30 – Afternoon Tea / Coffee

REGULATORY

15:50 - Panel Discussion: The developing regulatory frame work

•   Ever-changing global regulatory requirements – Where is the current stand?
•   What are the current regulatory and practical challenges of the Risk Management Plan and how can you identify potential improvements?
•   PV - Laws, Regulations, Guidelines and Best Practices
•   How do marketing authorisation holders ensure they are upto- date with current legal regulatory regulations and guidelines?
•   Up-to-date information on all aspects of compliance in pharmacovigilance (both pre-marketing and post-marketing)
•   The effect of Brexit on Pharmacovigilance

Moderator
BEN LOCWIN, Senior Vice President, Quality, Lumicell

Panellists
PHIL TREGUNNO, Group Manager - Vigilance, Intelligence and Research Group, MHRA (UK)
HEATHER LEIGH FLANNERY, Global Lead, ConsenSys Health
KATE GOFMAN, Medical Monitor & Pharmacovigilance Expert, Astrazeneca

16:30 – 16:40 – Chairperson’s closing remarks

Event Sponsors & Partners

We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!

Virtue Insight

CONCEPTUALISED BY

Clocate

SUPPORTED BY

Event Brite

SUPPORTED BY

GMP News

SUPPORTED BY

Farmavita

SUPPORTED BY

Bentham Science

SUPPORTED BY

Med Frogs

SUPPORTED BY

Testimonials

A huge thanks to all our sponsors, attendees and partners!

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Attendee List

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  • Date : 8 October 2019 - 9 October 2019
  • Time : 9:30 am - 6:00 pm (Asia/Kolkata)

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