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Forward Planning Analysis, Innovation, Patient Centricity and FDA Compliance as
a Strategic Framework To Execute Successful REMS Programs





AUGUST 2-3, 2022 | ALEXANDRIA, VA

REGISTER NOW
Download Brochure

Innovating in the REMS space is critical, not only talking about technology but
also talking about the approach with the FDA, the processes and the way we
communicate with all the stakeholders internal and external.  15 years have
passed since REMS was first implemented. We will deep dive into what has
happened in this time, how REMS has evolved, the progress we are seeing to
inform how the industry can optimize REMS moving forward in all stages.

This event will focus on how to work with sponsors and attract new ones,
analyzing the FDA new ideas in terms of patient wellness and participation. We
will focus on adjustments needed to stay up to date with technology, artificial
intelligence and new platforms, the focus on patient education and
prioritization for REMS and RMPs


MEET OUR SPEAKERS

Previous
Michele Riggen
Associate Director, KAB Programs

UBC

Carmit Strauss
Director, Global Safety (Benefit Risk Management Officer)

AMGEN

Bill Trombetta
Professor of Healthcare Strategy & Marketing

SAINT JOSEPH’S UNIVERSITY

Sheline Way
Associate Director, REMS Operations

TEVA PHARMACEUTICALS

Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance

ZOGENIX

Eleni Samaras Allen
Director, REMS Strategy and Execution

GSK

Nancy Dubois
Head of Global Patient Safety/US Region

EMD SERONO

Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

AMNEAL PHARMACEUTICALS

Kishore Gopu
Senior Director, REMS Operations

TEVA PHARMACEUTICALS

Suzanne Marinello
Risk Management Lead

JOHNSON & JOHNSON

Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS

LUPIN PHARMACEUTICALS

Catina O’Leary
President and CEO

HEALTH LITERACY MEDIA

Matt Page
Team Lead, Center for Post Approval Safety Studies

TAKEDA

Michele Riggen
Associate Director, KAB Programs

UBC

Carmit Strauss
Director, Global Safety (Benefit Risk Management Officer)

AMGEN

Bill Trombetta
Professor of Healthcare Strategy & Marketing

SAINT JOSEPH’S UNIVERSITY

Sheline Way
Associate Director, REMS Operations

TEVA PHARMACEUTICALS

Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance

ZOGENIX

Eleni Samaras Allen
Director, REMS Strategy and Execution

GSK

Nancy Dubois
Head of Global Patient Safety/US Region

EMD SERONO

Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

AMNEAL PHARMACEUTICALS

Kishore Gopu
Senior Director, REMS Operations

TEVA PHARMACEUTICALS

Suzanne Marinello
Risk Management Lead

JOHNSON & JOHNSON

Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS

LUPIN PHARMACEUTICALS

Catina O’Leary
President and CEO

HEALTH LITERACY MEDIA

Matt Page
Team Lead, Center for Post Approval Safety Studies

TAKEDA

Michele Riggen
Associate Director, KAB Programs

UBC

Carmit Strauss
Director, Global Safety (Benefit Risk Management Officer)

AMGEN

Bill Trombetta
Professor of Healthcare Strategy & Marketing

SAINT JOSEPH’S UNIVERSITY

Sheline Way
Associate Director, REMS Operations

TEVA PHARMACEUTICALS

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 * 9
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 * 13

Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance

ZOGENIX

Eleni Samaras Allen
Director, REMS Strategy and Execution

GSK

Nancy Dubois
Head of Global Patient Safety/US Region

EMD SERONO

Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

AMNEAL PHARMACEUTICALS

Kishore Gopu
Senior Director, REMS Operations

TEVA PHARMACEUTICALS

Suzanne Marinello
Risk Management Lead

JOHNSON & JOHNSON

Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS

LUPIN PHARMACEUTICALS

Catina O’Leary
President and CEO

HEALTH LITERACY MEDIA

Matt Page
Team Lead, Center for Post Approval Safety Studies

TAKEDA

Michele Riggen
Associate Director, KAB Programs

UBC

Carmit Strauss
Director, Global Safety (Benefit Risk Management Officer)

AMGEN

Bill Trombetta
Professor of Healthcare Strategy & Marketing

SAINT JOSEPH’S UNIVERSITY

Sheline Way
Associate Director, REMS Operations

TEVA PHARMACEUTICALS


VIEW ALL SPEAKERS


TOP REASONS TO ATTEND

 * Evaluate the use of AI in REMS for the greater good of every stakeholder,
   from patients to the FDA involvement
 * Optimize patient education, wellness and health literacy, the key elements to
   great and successful REMS programs
 * Develop best practices on how to efficiently document Safety and Adverse
   Events on REMS while remaining FDA compliant
 * Understand the impact and growth from telemedicine and how to accommodate in
   the REMS space
 * Analyze assessment metrics and determine the processes of approval for REMS
   programs
 * Review the evolution of REMS, success, pitfalls, room for improvement and the
   continued growth of the programs


WHO SHOULD ATTEND

This event is designed for pharmaceutical, biotech, and medical device
professionals with responsibilities in the following areas:

 * REMS
 * Benefit/Risk Management
 * Drug/Product Safety
 * Pharmacovigilance/Surveillance
 * Medical Direction
 * Quality Assurance
 * Clinical Risk Management
 * Life Cycle Management

 * Regulatory Affairs/Legal/Compliance
 * Clinical Affairs
 * Clinical Data Management
 * Clinical Operations
 * Clinical Risk Management Compliance
 * Epidemiology/Pharmacoepidemiology
 * Patient Centricity – Patient Wellness


THANK YOU TO OUR SPONSOR


If you’re interested in Sponsorship Opportunities, please contact Meg Larson at
meg@momentumevents.com


PRICING


PHARMACEUTICAL / MEDICAL DEVICES / BIOTECHNOLOGY


ADVANCED

Register by 07/01/2022
$1,695



STANDARD

Register by 08/01/2022
$1,795



ON SITE RATE

.
$1,895



SOLUTIONS PROVIDERS / VENDORS


ADVANCED

Register by 07/01/2022
$1,995



STANDARD

Register by 08/01/2022
$2,095



ON SITE RATE

.
$2,195



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