REMS2020

Call for Papers

The 12th REMS Summit convenes pharma, FDA, healthcare providers, and patient advocates to delve into specific topics to enhance the understanding of when REMS are necessary the elements that need to be included in the REMS needed for their product, as well as details required for submission. Our adept speaking faculty will arm you with proven strategies to facilitate benefit-risk counseling, optimize REMS operations through streamlined health system integration, leverage interoperable technologies for consistent communication, and increase patient safety through cross-functional collaboration. 

Top Five Reasons to Attend: 

*To assess REMS efficacy with proven methods from industry professionals 

*Complying with regulations pertaining to standardization and evaluation 

*Collaborate with industry leaders on innovative approaches for REMS design, implementation, and solutions 

*Increase knowledge and awareness of upcoming REMS technologies, innovation and regulatory changes 

*Discussing the challenges of recent FDA guidelines impacting REMS 

Who Should Attend: 

This event is ideal for professionals from payers and pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: 

REMS 

Risk Management 

Pharmacovigilance/Surveillance 

Quality Assurance 

Drug/Product Safety 

Clinical Risk Management 

Lifecycle Management 

Regulatory Affairs/Legal/Compliance 

Clinical Affairs 

Clinical Data Management 

Clinical Operations 

Clinical Risk Management Compliance 

Epidemiology/Pharmacoepidemiology 

Marketing 

Prices: 

Early Bird - Conference Industry: USD 1895.00 

Early Bird - Government/Academic: USD 1295.00 

Standard - Conference Industry: USD 2095.00 

Standard - Government/Academic: USD 1495.00 

Onsite - Conference Industry: USD 2295.00 

Onsite - Government/Academic: USD 1695.00 

Speakers: May Chan-Liston Director, CELGENE, Michele V. Davidson Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, WALGREENS CO, Jacqueline Gerena Director, REMS Program and Drug Safety Compliance, TITAN PHARMACEUTICALS, Romana Hosain Head of Risk Management, REGENERON PHARMACEUTICALS, INC., Cynthia Kear, MDiv Senior Vice President, CALIFORNIA ACADEMY OF FAMILY PHYSICIANS, John Klimek, R.Ph. SVP Standards and IT, NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS, INC., Elaine Lippman Regulatory Counsel, FDA, Reema Mehta Head of Risk Management Center of Excellence, PFIZER INCORPORATED, Seth Morgan Chair and Advocate, NATIONAL MULTIPLE SCLEROSIS SOCIETY, Elaine H. Morrato Special Government Employee FDA, Associate Dean for Public Health Practice, COLORADO SCHOOL OF PUBLIC HEALTH, Sharon Reid Risk Management Product Lead, PFIZER INCORPORATED, Annette Stemhagen, MPH, DrPH, Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC 

Time: 8:00 am to 5:00 pm