Pharmacovigilance Forum

Drug Safety, Adverse Events & REMS

March 4-6, 2020

San Diego, CA

Event Overview

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

Featured Session Topics:

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

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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Top 5 Reasons to Attend

  1. Acquire 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. Increase the efficacy of your post-market signal 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 Life Science Professionals responsible for:

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

THREE DAYS OF EDUCATION AND NETWORKING

DON'T MISS IT

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Wednesday, March 4th, 2020 | Pre-Conference Workshop


8:00 AM - 9:00 AM

Networking Breakfast & Workshop Registration

9:00 AM - 9:30 AM

Workshop Opening Remarks

9:30 AM - 10:45 AM

Part 1 - Pharmacovigilance (PV) Vendor Management &
Oversight 101

Attendees in this two-part deep-dive workshop of proven techniques & successful strategies for optimizing vendor management &relations will:

  • Examine tools & strategies to evaluate your needs & resources
  • Establish appropriate KPIs & benchmarks for your vendors
  • Discuss proven techniques to monitor these benchmarks
  • Learn pragmatic tips & actionable considerations for strategic outsourcing

Deepa Venkataraman, M. Pharm - Senior Director, Section Head, Drug Safety & Pharmacovigilance Operations
PHARMACYCLICS, AN ABBVIE COMPANY

Erica Bavol - Associate Director, Postmarketing PV Collaboration & Vendor Management
PHARMACYCLICS, AN ABBVIE COMPANY

10:45 AM - 11:00 AM

Networking & Refreshment Break

11:00 AM - 12:15 PM

Part 2 - Pharmacovigilance (PV) Vendor Management &
Oversight 101 - Continued

In the second session, participants will learn how to:

  • Identify signs that signal the need to change vendors
  • Look at proven methods to optimize the value of vendor partnerships
  • Explore effective strategies to ensure smooth, successful transitions to new vendors

Deepa Venkataraman, M. Pharm - Senior Director, Section Head, Drug Safety & Pharmacovigilance Ops
PHARMACYCLICS, AN ABBVIE COMPANY

Erica Bavol - Associate Director, Postmarketing PV Collaboration & Vendor Management
PHARMACYCLICS, AN ABBVIE COMPANY

12:15 PM - 12:45 PM

Open Forum Q&A

12:45 PM - 1:00 PM

Afternoon Networking & Refreshment Break

1:00 PM - 1:15 PM

Workshop Closing Remarks


Thursday, March 5th, 2020 | Day 1


8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Day One Opening Remarks

9:15 AM - 10:15 AM

Pharmacovigilance Regulations and Vendor Compliance

Participants in this multi-faceted session will learn answers to questions faced by most, if not all, pharmacovigilance teams, including:

  • Challenges and oversight—best practices for pharma and vendors
    • Does your vendor have the infrastructure to meet adverse event reporting requirements?
    • What are best practices for partnering with procurement & brand teams to maximize successful onboarding of vendors?
  • Effects of global, national & local regulations on regulation & compliance
    • How to more effectively communicate the “regulatory why”
    • What are proven implementation tips & strategies for successful, complete compliance?
    • Why is “the good old-fashioned phone call” key to vendor relationship building?
    • When is the right time to review & refine protocol for reconciling adverse events?
  • Specialty pharmacies – solutions to regulatory & reporting challenges
    • What are the unique challenges associated with overseeing specialty pharmacies?
    • Who can help identify FDA versus state pharmacy regulations?
    • Why do costs of adverse event reporting determine the type & depth of reporting?
    • How do regulations impact patient support programs?
  • Market research vendors
    • How do executives minimize the likelihood of soliciting vague or unintended adverse event reports while still meeting the objectives of the research?
    • What are preventative steps to ensure market research does not unintentionally clog a safety database?

Dawn Sczubelekk - Team Lead, Patient Safety Compliance & Enablement
AstraZeneca Pharmacueticals, LP

Susan Romanies - Senior Patient Safety Specialist
AstraZeneca Pharmacueticals, LP

10:15 AM - 10:30 AM

Networking & Refreshment Break

10:30 AM - 11:30 AM

Best Practices for Post-Market Signal Monitoring

Attend this program to:

  • Explore regulatory requirements for post-market safety surveillance
  • Identify pro-active precautions to avoid common pitfalls
  • Learn about building a robust PV framework to mitigate safety monitoring challenges 
  • Discuss critical tools to enable timely & effective post-market safety assessment

Cristina Damatarca - MD - Vice President, Drug Safety &. Pharmacovigilance
SAMUMED, LLC

Jina Shah, MD, MPH - Consultant
JINA SHAH MD CONSULTING SAMUMED, LLC

11:30 AM - 12:30 PM

Implementing and Overseeing Compliant and Effective Safety Data Exchange Agreements

Get ready to take notes from an accomplished pharmacovigilance director. Topics will include:

  • Evaluate prospective third-parties’ systems for management of safety information & regulatory compliance during due diligence
  • Examine differences in SDEAs for different types of third parties
  • Ensure SDEAs are comprehensive & sufficiently account for regulatory requirements
  • Audit SDEAs to ensure inspection readiness
  • Document essential data for capturing SDEAs within a quality management system

Keya Pitts, MPH - Head, Quality, Standards and Compliance Global Patient Safety and Risk Management (GPSRM)
ALNYLAM PHARMACEUTICALS 

12:30 PM - 1:30 PM

Networking Lunch

1:30 PM - 2:30 PM

CASE STUDY - Mastering the Basics of a Sound PV Quality Management System

The only constant in life is change! In this session, look at prospective changes in pharmacovigilance regulations & enhancements to improve monitoring. Share a case study & examples of KPIs that are not audited.

  • Walking through existing pharmacovigilance regulations & forecasting prospective future changes
  • Why is it crucial to have global pharmacovigilance processes & documentation?
  • What KPIs are audited & how do you align your performance indicators to assess the effectiveness of your quality management system?
  • Examples of KPIs that don’t get audited

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

2:30 PM - 2:45 PM

Networking & Refreshment Break

2:45 PM - 3:45 PM

Implementing an Effective Corrective and Preventative Action (CAPA) System

Session attendees will explore:

  • Building a CAPA system that effectively balances risk & investigative resources
  • Implementing CAPA earlier in your development process to mitigate downstream issues
  • Training to ensure CAPA methodologies are used appropriately organization-wide
  • Reviewing essentials to ensure standardization & consistency in results & outcomes
  • Identifying root causes in your corrective or preventative actions

3:45 PM - 4:45 PM

Networking Roundtables

Roundtable A:
Quality Management Systems & CAPA

Facilitator:
Jaylaxmi Nalawade, MD - Associate Director, Pharmacovigilance and REMS
Lupin Somerset

Roundtable B:
Safety Data Exchanges

Facilitator:
Deepa Venkataraman M.Pharm - Senior Director, Section Head, Drug Safety and Pharmacovigilance Ops
Pharmacyclics, an Abbvie Company

Roundtable C:
PV in the Asia-Pacific Market

Facilitator:
TBD

Roundtable C:
PV in the Asia-Pacific Market

Facilitator:
TBD

Roundtable F:
PV in the UK and EU

Facilitator:
TBD

 

4:45 PM - 5:00 PM

Day One Closing Remarks


Friday, March 6th, 2020 | Day 2


8:00 AM - 9:00 AM

Networking Breakfast

9:00 AM - 9:15 AM

Day Two Introduction

9:15 AM - 10:30 AM

Organizational Best Practices to Enhance Inspection-Readiness

First-hand account about walking through an inspection - expectations versus realities - inspection management tips & best practices

  • Identifying key information awareness for various departments & stakeholders
  • Inspection report preparedness
  • Incorporating vendors into inspection-preparedness efforts

Christine Borowsky - Senior Manager, Clinical Quality Assurance
Pharmacyclics, an Abbvie Company

10:30 AM - 10:45 AM

Networking & Refreshment Break

10:45 AM - 11:45 PM

Case Study: Optimizing Safety Surveillance and Externally Sponsored Research Studies

Rodrigo Pimentel - Senior Medical Director & Patient Safety Physician, Immuno-Oncology
AstraZeneca Pharmacueticals, LP

11:45 PM - 12:30 PM

Case Study: AI & Automation

12:30 PM - 1:30 PM

Networking Lunch

1:30 PM - 2:30 PM

Case Study: Title TBA

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

Jina Shah, MD - Consultant
Jina Shah MD Consulting

2:30 PM - 3:30 PM

Critical Considerations in the Transition to Automated Systems Implementation

This session will focus on practical tips & foundational information for acquiring & utilizing AI or machine learning platforms.

Participants will learn to:

  • Ensure system-to-system integration & avoid costly missteps with investments
  • Streamline processes and systems with internal teams and external stakeholders
  • Optimize systems alignment to account for custom input and research
  • Allow for adjustments to content collateral and usefulness for medical affairs

3:30 PM - 3:45 PM

Day Two Closing Remarks


FEATURING

Speakers & Faculty

Deepa Venkataraman

Deepa Venkataraman

Senior Director, Section Head, Drug Safety and Pharmacovigilance
Pharmacyclics LLC/Abbvie

Jina Shah

Jina Shah

Consultant
Jina Shah Consulting

Cristina Damatarca

Cristina Damatarca

Vice President, Drug Safety and Pharmacovigilance
Samumed, LLC

Erica Bavol

Erica Bavol

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

Rodrigo Pimentel

Rodrigo Pimentel

Senior Medical Director & Patient Safety Physician, Immuno-Oncology, Selumetinib &RhlA
AstraZeneca Pharmaceuticals

Dawn Sczubelekk

Dawn Sczubelekk

Team Lead, Patient Safety Compliance & Enablement
AstraZeneca Pharmaceuticals

Keya Pitts

Keya Pitts

Executive Director, Pharmacovigilance Quality Assurance
Astellas Pharma

Susan Romanies

Susan Romanies

Senior Patient Safety Specialist
AstraZeneca Pharmaceuticals

REGISTRATION & PRICING


CONFERENCE + WORKSHOPS

* SUPER EARLY BIRD *

Register by 12/20/19

$2,096

EARLY BIRD

Register by 1/24/20

$2,296

STANDARD

Register after 1/24/20

$2,496

ON-SITE

Register at Event

$2,696

CONFERENCE ONLY

* SUPER EARLY BIRD *

Register by 12/20/19

$1,496

EARLY BIRD

Register by 1/24/20

$1,696

STANDARD

Register after 1/24/20

$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

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 Amy Chapman at (561) 571-7687 or achapman@dgeconfs.com


MEDIA PARTNERS

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PREMIER MEDIA PARTNER