2019 Pharmacovigilance Forum

Signal Management

November, 2019

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


8:00 AM - 9:00 AM

Workshop Registration & Continental Breakfast

9:00 AM - 12:00 PM

Pharmacovigilance (PV) Vendor Management & Oversight 101

  • Examining tools and strategies that will help evaluate your needs and resources
  • Setting appropriate KPIs and benchmarks for your vendors
  • How to align your oversight efforts to monitor these benchmarks
  • Pragmatic tips and considerations to ensure you are outsourcing strategically
  • Signs that you may need to consider changing vendors
  • How do you build next-level partnerships with your vendors?
  • Effective management strategies to ensure transitions to new vendors are successful

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


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 - 10:15 AM

Pharmacovigilance Regulations and Vendor Compliance

  • Challenges and oversight—best practices for pharma and vendors
    • Does your vendor have the infrastructure to meet adverse event reporting requirements?
    • Partnering with procurement and brand teams to maximize successful onboarding of vendors
  • Examining global and local regulations
    • How to more effectively communicate the “regulatory why”
    • Proven implementation tips and strategies
    • Vendor relationship building – “the good old-fashioned phone call”
    • Methods for reconciling adverse events
  • Specialty pharmacies
    • What are the unique challenges associated with overseeing specialty pharmacies?
    • Detangling FDA versus state pharmacy regulations
    • Adverse event reporting—core service or enhanced service and at what cost?
    • Patient support programs—regulatory spotlight on pharma oversight
  • Market research vendors
    • How do you minimize the likelihood of soliciting vague or unintended adverse event reports, while still meeting the objectives of the research?
    • Preventative methods to ensure market research does not unintentionally clog your safety database

Dawn Sczubelek - 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

Practical Tips and Best Practices for Post-Market Signal Monitoring

  • Examine regulatory requirements for post-market monitoring and steps to avoid common pitfalls
  • Tips for building a robust PV framework to mitigate safety monitoring weaknesses
  • Critical tools you should implement to enable timely and effective post-market safety analyses
  • How to succeed if you’re not yet able to incorporate AI into your systems

Cristina Damatarca, MDVice President, Drug Safety and Pharmacovigilance
Samumed, LLC 

Jina Shah, MDConsultant
Jina Shah MD Consulting

11:30 AM - 12:30 PM

Implementing and Overseeing Compliant and Effective Safety Data Exchange Agreements

  • How to evaluate prospective third-parties’ systems for management of safety information and regulatory compliance during due diligence
  • Examine differences in SDEAs for different types of third-parties
  • Steps to ensure your SDEAs are comprehensive and sufficiently account for regulatory requirements
  • How should you be auditing your SDEAs to ensure inspection-readiness?
  • Documentation essentials for capturing your SDEAs within your quality management system

Keya Pitts, MPH - Executive Director, Pharmacovigilance Quality Assurance
Astellas Pharma

12:30 PM - 1:30 PM

Networking Lunch

1:30 PM - 2:30 PM

Mastering the Basics of a Sound PV Quality Management System

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

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

  • How to build a CAPA system that effectively balances risk and investigative resources
  • Keys to implementing CAPA earlier in your development process to mitigate downstream issues
  • Training strategies to ensure your CAPA methodologies is used appropriately organization-wide
  • Management review essentials to ensure standardization and consistency in results and outcomes
  • Tips for effectively 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 E:
Adapting to Changes inDomestic  &  Global Regulations

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


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

Organizational Best Practices to Enhance Inspection-Readiness

  • Walking through our inspection—what we expected versus what happened
  • Inspection management tips and best practices
  • Identifying key information different departments and stakeholders need to be aware of
  • What you need to know about the inspection report
  • How do you effectively incorporate 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 - 3:15 PM

Critical Considerations in the Transition to Automated Systems Implementation

Whether you are currently utilizing AI or machine learning platforms, are ready to invest in advanced systems, or are looking for first-steps toward implementation of these platforms, this session will focus on practical tips and foundational information you need to:

  • Ensure system-to-system integration and avoid costly missteps with your 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

Chairperson's 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

STANDARD

Prior to Event

$2,596

ON-SITE

Register at Event

$2,796

CONFERENCE ONLY

STANDARD

Prior to Event

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