19th Pharmacovigilance 2019

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