DIA 2021 Virtual Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.

Learning Objectives

Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.

Chair

Jesper Kjær, MS

Speaker

DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Stine Hasling Mogensen, MPharm

Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Anton Pottegaard, DrSc, PhD, MPharm

Off-Label Use Monitoring Through Danish Registries
Mona Vestergaard Laursen, MPharm

FDA Real-World Evidence Activities Related to Covid19
Mitra Rocca, MSc

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
Richard Forshee, PhD

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-586-L04-P; CME 1.00; IACET 1.00; RN 1.00

Three routes to access unproven treatments outside of clinical trials will be presented, using Covid-19 as a case study. Presenters will address legal/regulatory, ethical, and pragmatic issues concerning patient care and medical research.

Learning Objectives

Discuss three routes - EUA, non-trial preapproval access (Expanded Access and Right to Try), and off-label use of an approved product – by which patients may receive unproven treatments outside of clinical trials; Describe the trade-offs inherent in providing access to unproven treatments in the context of Covid-19.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Panelist
Holly Fernandez Lynch, JD, MA

Panelist
Christopher Robertson, JD, PhD, LLM

Panelist
Paul Aliu, PharmD, MBA, RPh, PMP

Component Type: Forum

Join DIA Clinical Safety and Pharmacovigilance Community for a round table discussion tied to session #502 OD Artifical Intelligence: Real Applications and Regulatory Perspectives. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Chair

Jeremy Jokinen, PhD, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-614-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will explore the use of different evaluation designs and measurement approaches to advance the science of risk minimization program evaluation and include a recent case study to illustrate points.

Learning Objectives

Define methodologic features of high-impact risk minimization program evaluation designs; Review existing risk evaluation and mitigation strategies (REMS) case studies and opportunities to improve their evaluation, including consideration of contextual factors and assessment of potential burden on the healthcare system; Describe how to improve the likelihood of publication of evaluation studies.

Chair

Meredith Smith, PhD, MPA, FISPE

Speaker

Panelist
Almut G Winterstein, PhD, RPh, FISPE

Panelist
Giampiero Mazzaglia, MD, PhD, MSc

Panelist
Rachael L. DiSantostefano, PhD, MS

Panelist
Vincent Lo Re, MD, MS, FISPE

Panelist
Gianluca Trifiro, MD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-635-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will focus on best practices and lessons learned for the development and implementation of Shared REMS. These topics will be discussed from the perspectives of the FDA, leaders in industry, and other stakeholders.

Learning Objectives

Identify changes to the REMS statute through the Appropriations Act of 2020; Describe challenges for design and implementation during the development of Shared REMS; Describe processes and challenges for REMS that incorporate >1 product from a single applicant; Discuss best practices for the development of a shared REMS and incorporation of new products into an existing REMS program.

Chair

Jacqueline Sheppard, PharmD

Speaker

FDA Update
Laura Zendel, PharmD

Industry Update
Kevin Holman, MBA, RAC

Industry Update
Kishore Gopu, MBA, MS

Industry Update
Jemma Contreras, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-658-L04-P; CME 1.00; IACET 1.00; RN 1.00

The principle of patient-centric labeling and assessing safety will be discussed to seek an opportunity for international harmonization for implementing earlier access to medicines as the breakthrough risk communication.

Learning Objectives

Describe the current challenges for risk communication to patients across regions; Identify the future breakthrough risk communication to patients and principle of patient-centric labeling; Discuss how to assess safety after early access to Pharmaceuticals; Discuss how to measure the effectiveness of risk communication/patient-centric labeling.

Chair

Rie Matsui, RPh

Speaker

Postmarket Safety Label Changes: Relationship to Development Pathways
Gerald J. Dal Pan, MD, MHS

Communication with Public/Patients to Promote Appropriate use of Medical Products in Japan
Junko Sato, PhD

Patient Labeling: Current State and Future Directions
Meredith Smith, PhD, MPA, FISPE