The 2019 Pharmacovigilance Forum

Best Practices to Improve PV Vendor Management, Quality Management Systems and Signals Monitoring

July 22-24, 2019 | San Diego, CA

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Event Overview

With a strong focus on vendor management, quality management systems, and signals management, this conference will give you proven best practices, inspection-based lessons learned, and practical tips and tools to enhance your pharmacovigilance & drug safety systems.

Featured Session Topics:

  • Panel Discussion: Adapting to Changes in Domestic & Global Regulations
  • Practical Tips and Best Practices for Post-Market Signal Monitoring
  • Proven Methods to Enhance Data Collection and Management to Enable Timely Detection
  • Organizational Best Practices to Enhance Inspection-Readiness
  • Critical Considerations in the Transition to Automated Systems Implementation

Plus, don’t miss our special two-part pre-conference workshop on Pharmacovigilance Vendor Management and Safety Data Exchange Agreements!

Wyndham Bayside San Diego

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1355 N Harbor Dr.
San Diego, CA 92101
(619) 232-3861

Hotel Website

Special Event Rate
Coming Soon

Top 5 Reasons to Attend

  1. Get tools and proven strategies to more effectively manage your PV vendors and service providers
  2. Strengthen the compliance of your Safety Data Exchange Agreements to ensure inspection-readiness
  3. Learn how your peers and competitors are adapting to changes in global drug safety regulations
  4. Enhance the efficacy of your post-market signals monitoring and mitigate safety monitoring weaknesses
  5. Enable risk-based resource allocation with Corrective and Preventative Action (CAPA) best practices

Attendee Profile

This conference is designed for senior leaders and executives in pharmaceutical and biotech companies responsible for:

  • Pharmacovigilance and epidemiology
  • Drug Safety and public health
  • Signal detection & surveillance
  • Quality management and quality assurance
  • Compliance
  • Vendor management & oversight
  • Inspection readiness
  • Audits
  • Analytics
  • Data management

Monday, July 22nd, 2019 | Pre-Conference Workshop


8:00 AM - 9:00 AM

Workshop Registration & Continental Breakfast

9:00 AM - 12:00 PM

Part One: Pharmacovigilance (PV) Vendor Management & Oversight 101 

Deepa Venkataraman, M.Pharm, Senior Director, Section Head, Drug Safety and Pharmacovigilance Operations
Pharmacyclics, An Abbvie Company

Erica Bavol, Associate Director, Postmarketing PV Collaboration and Vendor Management
Pharmacyclics, An Abbvie Company

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 4:00 PM

Part Two: Implementing and Overseeing Compliant and Effective Safety Data Exchange Agreements


Tuesday, July 23rd, 2019 | Day 1


8:00 AM - 9:00 AM

Registration & Breakfast

9:00 AM - 9:15 AM

Chairperson's Opening Remarks

9:15 AM - 10:30 AM

Panel Discussion: Adapting to Changes in Domestic & Global Regulations

10:30 AM - 11:00 AM

Networking & Refreshment Break

11:00 AM - 12:00 PM

Practical Tips and Best Practices for Post-Market Signal Monitoring

Cristina Damatarca, MD,  Vice President, Drug Safety and Pharmacovigilance
Samumed, LLC 

Jina Shah, MD,  Consulting
Former Sr Medical Director, Bioethics and Sr. Safety Science Leader, Genentech

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 2:00 PM

Critical Considerations in the Transition to Automated Systems Implementation

2:00 PM - 2:45 PM

Featured Two-Part Session on Quality Management Systems

Part I: Mastering the Basics of a Sound PV Quality Management System

Jaylaxmi Nalawade, MD, Associate Director, Pharmacovigilance and REMS
Lupin Somerset

2:45 PM - 3:15 PM

Networking & Refreshment Break

3:15 PM - 4:00 PM

Part II: Implementing an Effective Corrective and Preventative Action (CAPA) System

4:00 PM - 5:00 PM

Networking Roundtables

Roundtable A: AI & Automation

Roundtable B: Quality Management Systems & CAPA

Facilitator:

Jaylaxmi Nalawade, MD, Associate Director, Pharmacovigilance and REMS
Lupin Somerset

Roundtable C: PV in the Asia-Pacific Market

Roundtable D: Safety Data Exchanges

Roundtable E: Signal Detection Best Practices

Roundtable F: PV in the UK & EU

5:00 PM - 5:15 PM

Day One Closing Remarks


Wednesday, July 24th, 2019 | Day 2


8:00 AM - 9:00 AM

Networking Breakfast

9:00 AM - 9:15 AM

Chairperson's Recap of Day One

9:15 AM - 10:30 AM

Developing Technical Messaging that Exceeds Education Needs

10:30 AM - 11:00 AM

Networking & Refreshment Break

11:00 AM - 12:00 PM

Proven Methods to Enhance Data Collection and Management to Enable Timely Detection & Surveillance

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:30 PM

Featured Two-Part Session: Signal Monitoring Case Studies

Case Study I: TBA

Cristina Damatarca, MD,  Vice President, Drug Safety and Pharmacovigilance
Samumed, LLC 

Jina Shah, MD,  Consulting
Former Sr Medical Director, Bioethics and Sr. Safety Science Leader, Genentech

1:30 PM - 1:45 PM

Networking & Refreshment Break

1:45 PM - 2:15 PM

Case Study II: TBA

2:15 PM - 2:30 PM

Joint Q&A

2:30 PM - 3:15 PM

Methods to Enhance PV Vendor Management to Improve Quality Oversight

3:15 PM - 3:30 PM

Chairperson’s Closing Remarks


FEATURING

Speakers & Faculty

Nneka Onwudiwe

Nneka Onwudiwe

PRO/PE Regulatory Review Officer
FDA

Tehseen Salim

Tehseen Salim

Head of Medical Affairs – Primary Care and Women’s Health
Merck

Chris Boone

Chris Boone

Vice President, Head of Real World Data and Analytics Center of Excellence
Pfizer

Rosh Dias

Rosh Dias

Former Vice President, Global Scientific Affairs
Amgen

 
Michael Jarjour

Michael Jarjour

Former CEO at Otsuka Digital Health
ACMA Board Member

Robert P. Stevens

Robert P. Stevens

Executive Director & Head, Digital Strategy & Medical Innovation
Novartis

 

REGISTRATION & PRICING


CONFERENCE + WORKSHOPS

EARLY BIRD

Until 5/22/19

$2,396

STANDARD

After 5/22/19

$2,596

ON-SITE

Register at Event

$2,796

CONFERENCE ONLY

EARLY BIRD

Until 5/22/19

$1,696

STANDARD

After 5/22/19

$1,896

ON-SITE

Register at Event

$2,096

Register 2 Attendees, Get 1 Complimentary Registration*!

Interested in sending groups of 7 or more? Contact us directly for pricing.

* Standard Pricing Only

THREE DAYS OF EDUCATION AND NETWORKING

DON'T MISS IT

REGISTER NOW

EVENT SPONSORS

SPONSOR THIS EVENT

Are you a vendor, consultancy, or solutions provider? Our attendees want to hear what you have to offer their organization. We can customize sponsorship packages tailored to your marketing needs.

Please contact James Lauriello at (561) 221-6218 or jlauriello@dgevents.com