DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000192; RN 1.00

This session will explore key aspects necessary for success when integrating regulatory operations teams as a result of mergers and acquisitions.

Learning Objectives

Discuss the necessary elements for successfully integrating regulatory operations departments during a merger or acquisition; Identify risks related to migrating information between systems; Respond to questions from others in the organization on best practices for integrating regulatory solutions.

Chair

Sarah Powell, RAC

Speaker

Challenges and Business Impact Associated with Mergers and Acquisitions
Meredith K Sewell

Building a Regulatory Information Management Capability for the Next Decade: People, Process, and Technology - Case Study
Dominique E. Lagrave

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-597-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000184; RN 1.25

As more countries adopt cost containment strategies, it becomes increasing difficult to plan and execute successful, global launches of new drugs. This session will provide an overview of how to plan a successful launch given these challenges.

Learning Objectives

Identify the variables which influence the price of new drugs; Explain how international reference pricing affects optimal launch sequence; Recognize the other considerations (e.g., country scope, intellectual property, clinical plan) when planning a successful launch.

Chair

Matthew Steven Curin, PharmD

Speaker

What Every Project Manager Should Know about HTA and Pricing
Claire Corry, MS

Mapping the Global Launch Sequence in a Partnership
Nathan J. Murray

Practical Application of Global Launch Best Practices
Matthew Steven Curin, PharmD