RAPS Workshop: Adverse Events of Special Interest — Where We Are and What’s Next?

Registration Fees & Deadlines

Learning Objectives

•  Understand what the key aspects are for developing an AESI program
• Describe the cross functional areas’ roles for the AESI program development
• Define a strategy for assessing and monitoring AESIs

Who Should Attend?

Drug safety and pharmacovigilance professionals Regulatory affairs professionals Clinical development leads and scientists

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Cristina Dematarca MD
President, Safe Pharm, LLC

Cristina Damatarca has over 20 years’ experience in the biopharmaceutical industry across all stages of development and product commercialization, and has worked in Drug Safety and Pharmacovigilance in multiple leadership capacities, most with global responsibilities. Cristina received a medical degree from the University of Medicine and Pharmacy in Iasi, Romania, and a PgDip in Pharmacovigilance from the University of Hertfordshire, U.K. Cristina held positions of Vice President and Global Head of Drug Safety and Pharmacovigilance at several pharmaceutical companies of various sizes, she has built multiple safety departments from ground up, and played key roles in cross functional collaborations for safety evaluation and benefit-risk assessment for new and existing products. Cristina also served in senior roles in the industry including Therapeutic Area Head for the Oncology Signaling Franchise at Genentech-Roche, Global Safety Officer and Chair of the Global Safety Forum at Amgen, and worked in drug safety as Global Safety Officer at other global companies. During her tenure in drug safety and pharmacovigilance at various pharmaceutical companies, Cristina participated in several successful NDA/BLA/MAA filings, Drug Advisory Committees, established the drug safety governance and chaired the company's Drug Safety Committee for multiple organizations, and led the teams who developed REMS - RiskMAP – risk management programs for various products, some of these having played a key role in optimizing the benefit-risk profile of the products. In addition to her work experience in drug safety and pharmacovigilance, Dr. Damatarca spent several years of her career in Medical Education as Executive Director of Medical Education, Patient Outcomes, and Risks Management at the Neuroscience Education Institute where she provided oversight for the Continuing Medical Education department and led a team of scientists in developing educational programs (CME) in support of Risk Management for various pharmaceutical products. Many of these programs received recognition for innovation and excellence in medical education. Dr. Damatarca has published in peer-reviewed journals, including publications in the area of drug safety and pharmacovigilance, and had multiple speaking engagements at various pharmacovigilance and risk management conferences.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions