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Pharmacovigilance Forum Drug Safety, Adverse Events & REMS

March 4-6, 2020 San Diego, CA

Sponsored by Dynamic Global Events

Click Here to register $1696.00 until January 24.
(Register two attendees and third registration is complimentary!)

Click Here to download agenda

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

AGENDA

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 - 1:45 PM

Networking & Refreshment Break

1:45 PM - 2:00 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

Chairperson's Day 1 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 - 11:15 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 - Executive Director, Pharmacovigilance Quality Assurance
Astellas Pharma

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

Chairperson’s Day 1 Recap & Day 2 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

Chairperson's Closing Remarks

 

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