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Tuesday, January 19
 

10:00am EST

Chairpersons Opening Remarks
Tuesday January 19, 2021 10:00am - 10:05am EST

10:05am EST

UBC Presents The Latest in REMS To Increase Your Understanding & Operational Efficiencies
Speakers
avatar for Natalie O'Donnell

Natalie O'Donnell

Corporate Vice President, REMS, Safety and Strategic Engagement, UBC
Mrs. O’Donnell leads the UBC REMS SERRM team that develops REMS strategies, develops REMS and REMS Supporting Documents and leads the REMS evaluations.Mrs. O’Donnell’s background includes more than 20 years of healthcare and clinical research experience and has worked in the... Read More →
avatar for Rachel Bonfanti

Rachel Bonfanti

Director, Risk Management and Scientific Consulting, UBC
Ms. Bonfanti collaborates with UBC safety scientists and operational teams in  risk management consulting (including Risk Evaluation and Mitigation Strategy (REMS) contingency planning), is part of the REMS Assessment Team, and oversees the project management office (PMO) services... Read More →


Tuesday January 19, 2021 10:05am - 10:35am EST

10:40am EST

BMS REMS Innovations
Speakers
avatar for Nathalie Sweeney

Nathalie Sweeney

REMS Advisor, Senior Manager, BMS
Nathalie Sweeney is a Senior Manager, REMS Advisor, Global Risk Management, Worldwide Patient Safety for Bristol Myers Squibb (BMS). For the past 3 years, Nathalie’s focus has been to provide consulting support to all internal and external REMS stakeholders for BMS’s... Read More →
avatar for Jason Ancell

Jason Ancell

Associate Director, Global Risk Management Strategy, REMS Development, Implementation & Operations, BMS
Jason Ancell is Associate Director, Global Risk Management for Bristol Myers Squibb (BMS).  In his current role, Jason provides risk management support for BMS’s immunomodulatory drug class, including U.S. REMS.  Jason has over twelve years’ U.S. REMS experience; ranging from... Read More →


Tuesday January 19, 2021 10:40am - 11:10am EST

11:15am EST

Panel: Establishing Industry-Wide Standardized Training for REMS
Speakers
avatar for Kevin Holman

Kevin Holman

Director of REMS, Janssen
Kevin Holman, MBA, RAC leads the REMS and Risk Management Center of Excellence at Janssen Pharmaceuticals, where he built and leads a team that oversees the design, implementation, management, and assessment of risk management programs in the U.S. Throughout his career, Kevin has... Read More →
avatar for Sherice Mills

Sherice Mills

Sr. Director, Benefit-Risk Management, Jazz Pharmaceuticals
Introducing Risk Evaluation and Mitigation Strategies (REMS) enthusiast, Sherice Mills, who has had theopportunity to work on many of the industry’s shared REMS programs in place today. She is a SeniorDirector and currently leads the Benefit Risk Management group at Jazz Pharmaceuticals... Read More →
avatar for May Chan Liston

May Chan Liston

Executive Director, Global Risk Management, BMS
avatar for Suzanne McLeod

Suzanne McLeod

Manager, REMS and Drug Safety, Hikma Pharmaceuticals
Suzanne McLeod is a graduate of Austin Peay State University and began her work in the generic pharmaceutical industry in 2008. Suzanne is currently a Manager of REMS for Hikma Pharmaceuticals USA Inc. She has been involved in building and implementing shared REMS programs since 2009... Read More →


Tuesday January 19, 2021 11:15am - 11:55am EST

12:00pm EST

Zoom Breakout Rooms/Networking Break
Tuesday January 19, 2021 12:00pm - 1:00pm EST

1:00pm EST

Explore REMS from a Pharmacy Point of View
Speakers
avatar for Michele V. Davidson, R.Ph.

Michele V. Davidson, R.Ph.

Senior Manager, Pharmacy Technical Standards, Development & Policy, Government Relations, Walgreens Co.
Michele is the Senior Manager, Pharmacy Technical Standards, Development & Policy, Government Relations at Walgreens. Michele leads efforts within Walgreen to influence public policy as it applies to pharmacy technical standards. She actively engages and advises members of the government... Read More →


Tuesday January 19, 2021 1:00pm - 1:30pm EST

1:35pm EST

Fireside Chat: How to Work with Cross Functional Teams such as Organization Appointed Vendors
Speakers
avatar for Jacqueline Gerena

Jacqueline Gerena

Director of REMS Management, Aimmune
Jacqueline Gerena transitioned into the pharmaceutical industry from the private payer area of healthcare over a decade ago. In the pharmaceutical industry she has concentrated on patient support and patient safety programs; having held roles of increasing responsibility that focused... Read More →
avatar for Mario Mendoza

Mario Mendoza

BioExecutive In Residence, Stony Brook University
Dr. Mario R Mendoza is a clinical anesthesiologist (practiced at the NIH), chemist, and currently an independent healthcare and pharma medical affairs consultant with over 13 years of combined experience in patient care, clinical development, R&D, medical affairs (Abbott, Pfizer and... Read More →


Tuesday January 19, 2021 1:35pm - 2:15pm EST

2:20pm EST

Chairpersons Closing Remarks
Tuesday January 19, 2021 2:20pm - 2:30pm EST

2:30pm EST

Zoom Breakout Rooms/Networking Break
Tuesday January 19, 2021 2:30pm - 3:00pm EST
 
Wednesday, January 20
 

10:00am EST

Chairpersons Opening Remarks
Wednesday January 20, 2021 10:00am - 10:05am EST

10:05am EST

Compare REMS Standards to Global Counterparts such as RMPs
Speakers
avatar for Colleen Walsh

Colleen Walsh

Senior Director, Regional Safety Excellence, Alexion Pharmaceuticals
Colleen Walsh, Head, Regional Safety Excellence US and Canada, at Alexion is responsible for implementation and oversight of Alexion’s REMS programs. She also has extensive experience with European RMPs, including remediation and re-design of two RMP programs in response to critical... Read More →


Wednesday January 20, 2021 10:05am - 10:35am EST

10:40am EST

Roundtable Discussion: Hot Topics in Risk Management for 2021
Speakers
avatar for Reema Mehta

Reema Mehta

Senior Director, Head of Risk Management and Safety Surveillance Research, Pfizer
Reema Mehta, PharmD, MPH is Head of the Risk Management Center of Excellence at Pfizer, Inc. where she is responsible for providing strategic guidance for the development and execution of global risk management for Pfizer’s portfolio of products, innovation and research for risk... Read More →
avatar for Jamie Wilkins

Jamie Wilkins

Director, Risk Management Product Lead, Pfizer
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio in her... Read More →


Wednesday January 20, 2021 10:40am - 11:10am EST

11:15am EST

Panel: Evaluate if your Organizations REMS Program Should be Outsourced or Developed Internally
Speakers
avatar for Debbie Cheslow

Debbie Cheslow

Director, Risk Management Programs, PPD
Debbie Cheslow is a Director at PPD, a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Ms. Cheslow provides oversight for all REMS programs in the Peri and Post Approval Research Operations group... Read More →
avatar for Jason Ancell

Jason Ancell

Associate Director, Global Risk Management Strategy, REMS Development, Implementation & Operations, BMS
Jason Ancell is Associate Director, Global Risk Management for Bristol Myers Squibb (BMS).  In his current role, Jason provides risk management support for BMS’s immunomodulatory drug class, including U.S. REMS.  Jason has over twelve years’ U.S. REMS experience; ranging from... Read More →
avatar for Kishore Gopu

Kishore Gopu

Director, REMS Operations, Teva Pharmaceuticals
Kishore Gopu, M.S, MBA, is Director, REMS Operations and has been with Teva since 2007 and has served in many departments including Regulatory Affairs, Commercial Operations, Patient Solutions, Market Access, and Pharmacovigilance. Since joining Teva, Kishore has built REMS department... Read More →
avatar for Kal Elhoregy

Kal Elhoregy

Director REMS Programs, Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 23+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Compliance for companies within the pharmaceutical industry.In his current role as a... Read More →


Wednesday January 20, 2021 11:15am - 11:55am EST

12:00pm EST

1:00pm EST

NCPDP Standards Update — Navigate NCPDP Initiatives, Guidance and Future Proposals for Innovation
Speakers
avatar for John Klimek

John Klimek

SVP Standards and Information Technology, NCPDP
John Klimek R.Ph. is SVP, standards and industry information technology with the National Council for Prescription Drug Programs. His main objective is to work with industry leaders in healthcare to achieve interoperability amongst the healthcare standards, which will ultimately increase... Read More →


Wednesday January 20, 2021 1:00pm - 1:30pm EST

1:35pm EST

Fireside Chat: Explore the Integral Link Between Patients, Providers and Life Science Organizations
Speakers
avatar for Catina O'Leary

Catina O'Leary

President, Health Literacy Media
As President and CEO at Health Literacy Media (HLM), Catina O’Leary, PhD, LMSW oversees core activities and works to set and maintain the strategic vision for the organization. Catina has steered HLM onto the course of becoming a true partner to a broad spectrum of health care organizations... Read More →
avatar for Deborah Collyar

Deborah Collyar

Founder and President, Patient Advocates in Research


Wednesday January 20, 2021 1:35pm - 2:15pm EST

2:20pm EST

Chairpersons Closing Remarks
Wednesday January 20, 2021 2:20pm - 2:30pm EST

2:30pm EST

Zoom Breakout Rooms/Networking Break
Wednesday January 20, 2021 2:30pm - 3:00pm EST
 
Thursday, January 21
 

10:00am EST

Chairpersons Opening Remarks
Thursday January 21, 2021 10:00am - 10:05am EST

10:05am EST

Assess Outsourcing Options in Pharmacovigilance
Speakers
JN

Jaylaxmi Nalawade

Associate Director - Pharmacovigilance and REMS, Lupin Pharmaceuticals


Thursday January 21, 2021 10:05am - 10:35am EST

10:40am EST

Risk Management Compliance Stakeholders, Sponsors, Audits, Inspection and Readiness
Speakers
avatar for Kyle Irwin

Kyle Irwin

Operations Lead - REMS and Risk Management, Janssen
Kyle Irwin is the Operations Lead at Janssen Pharmaceuticals, REMS & Risk Management Center of Excellence.  At Janssen, Kyle leads the transition of REMS programs towards a standardized operational model, and provides consulting support for the development, implementation, and operations... Read More →
avatar for Reema Mehta

Reema Mehta

Senior Director, Head of Risk Management and Safety Surveillance Research, Pfizer
Reema Mehta, PharmD, MPH is Head of the Risk Management Center of Excellence at Pfizer, Inc. where she is responsible for providing strategic guidance for the development and execution of global risk management for Pfizer’s portfolio of products, innovation and research for risk... Read More →
avatar for Kal Elhoregy

Kal Elhoregy

Director REMS Programs, Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 23+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Compliance for companies within the pharmaceutical industry.In his current role as a... Read More →


Thursday January 21, 2021 10:40am - 11:10am EST

11:15am EST

Fireside Chat: Examine Combination Product Safety and its Impact on Pharmacovigilance
Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Executive Medical Director, Combination Product Safety, Amgen
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.  Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held... Read More →
avatar for Susan Neadle

Susan Neadle

Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
Susan Neadle has worked in the health care industry for over 30 years. Her distinguished career includes integral leadership roles in R&D, Quality Engineering, and Quality Systems Management, spanning pharmaceuticals, medical devices, and consumer products. In her current role, Sr... Read More →


Thursday January 21, 2021 11:15am - 11:55am EST

12:00pm EST

Zoom Breakout Rooms/Networking Break
Thursday January 21, 2021 12:00pm - 1:00pm EST

1:00pm EST

Explore Safety from a Drug/Compound View in Addition to a Clinical Trial View
Speakers
avatar for Adrian Dana

Adrian Dana

VP Drug Safety and PV, Johnson & Johnson


Thursday January 21, 2021 1:00pm - 1:30pm EST

1:30pm EST

Chairpersons Closing Remarks
Thursday January 21, 2021 1:30pm - 1:40pm EST

1:40pm EST

Zoom Breakout Rooms/Networking Break
Thursday January 21, 2021 1:40pm - 2:10pm EST
 
Friday, January 22
 

10:00am EST

Chairpersons Opening Remarks
Friday January 22, 2021 10:00am - 10:05am EST

10:05am EST

Analyze Advanced Tech in PV such as AI and Automation
Speakers
avatar for Sameer Thapar

Sameer Thapar

Professor of Drug Safety and Pharmacovigilance, Temple University School of Pharmacy
Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and concurrently, holds an academic role of Adjunct Professor, Drug Safety and Pharmacovigilance.  Dr. Thapar has extensive years... Read More →


Friday January 22, 2021 10:05am - 10:35am EST

10:40am EST

Explore how Clinical Operations Extracts Data and Disseminates it Regarding Drug Safety
Speakers
avatar for Toyin Adewole

Toyin Adewole

Associate Director of Drug Safety, Supernus Pharmaceuticals
Dr. Toyin Adewole is a Drug Safety Professional who oversees/leads the drug safety/pharmacovigilance operations and medical monitoring activities at Supernus Pharmaceuticals. She is experienced in different therapeutic areas including Infectious Diseases, Neurology, Oncology, Psychiatry... Read More →


Friday January 22, 2021 10:40am - 11:10am EST

11:15am EST

Panel: Assess the Validity of AI and New Tech in PV
Speakers
avatar for Deepa Venkataraman

Deepa Venkataraman

Senior Director, Head of Global Case Management, Medical Coding and Medical Safety Operations, Abbvie
avatar for Rahul Khajuria

Rahul Khajuria

Senior Director, Global Head of Drug Safety Systems and Analytics, United Therapeutics Corporations
Rahul Khajuria, Senior Director, Global Product Safety & PV Systems & Analytics:• has been working with UT in Global Product Safety and Pharmacovigilance since March 2017.• More than 14 years pharmacovigilance, drug safety with vast experience in data warehousing /business intelligence... Read More →
avatar for Michael Glaser

Michael Glaser

Innovation Technology Director, Safety, GSK
Michael Glaser, MSEE & MBA, is the Innovation Technology Director within the PV Safety organization at GlaxoSmithKline. Michael has over two decades of experience in the areas of hardware and software design, product management, and technology advocation. At GlaxoSmithKline, Michael... Read More →
avatar for Deanna Montes De Oca

Deanna Montes De Oca

Head of Global Case processing; Director PV Operations, Otsuka
Deanna Montes de Oca, PharmD is the Global Head of Case processing, Director of Global Pharmacovigilance at Otsuka. Deanna has been collaborating in the pharmaceutical industry within the pharmacovigilance space for over 17 years. She enjoys traveling, cooking, gardening, and spending... Read More →


Friday January 22, 2021 11:15am - 11:55am EST

12:00pm EST

Zoom Breakout Rooms/Networking Break
Friday January 22, 2021 12:00pm - 1:00pm EST

1:00pm EST

Explore the Role of VAERS and its Impact on Signal Detection
Speakers
avatar for Israel Gutierrez

Israel Gutierrez

VP of Drug Safety and Pharmacovigilance, Geron Corporation
Israel is an accomplished Global Executive with 24 years of experience building multi-therapeutic area medical affairs, clinical development, and drug safety. He has been working with multiple companies in many layers of executive management in the areas of Drug development, Risk... Read More →


Friday January 22, 2021 1:00pm - 1:30pm EST

1:30pm EST

Chairpersons Closing Remarks
Friday January 22, 2021 1:30pm - 1:40pm EST

1:40pm EST

Zoom Breakout Rooms/Networking Break
Friday January 22, 2021 1:40pm - 2:10pm EST