DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA

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

The session will review the implementation status of the 2010 EU Pharmacovigilance Legislation and its associated Good Pharmacovigilance Practices Guidelines, focusing on the key challenges and uncertainties arising from implementation, as well as some future proposals to measure impact on facilitating the performance of pharmacovigilance in the European Union. Did it do what it originally set out to achieve? Key to the success of implementing a robust pharmacovigilance system is the ability to strengthen the monitoring of benefit risk throughout a products life cycle. The results of the PROTECT work stream that arose as a quantum leap forward in benefit risk evaluation from the Innovative Medicines Initiative in the EU will be explored and how the results have changed industry and regulatory authority standards.

Learning Objectives

Discuss the current status, challenges, and uncertainties arising from the implementation of the EU Good Pharmacovigilance Practices Guidelines associated with the 2010 EU Pharmacovigilance Legislation; Describe future strategies to measure the impact that the legislation and guidelines have had since implementation; Explore how the results of PROTECT have changed industry and regulatory standards.

Chair

Valerie E. Simmons, MD, FFPM

Speaker

Introduction, General Overview of Implementation of the EU GVP Guidelines: Did They Actually Deliver?
Valerie E. Simmons, MD, FFPM

IMI PROTECT: Challenges, Successes, and the Effect on PhV in Europe
Stella C.F. Blackburn

Important Risks Resulting from EU PV Legislation and Guidance: Best Practice to Allow Optimized Patient Safety?
Leonardo Ebeling

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: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will involve a panel and analyze the ClinicalTrials.gov Final Rule, discuss how companies are navigating the US and EU disclosure/transparency mandates, and discuss data sharing expectations.

Learning Objectives

Identify the requirements of the Final Rule expanding the ClinicalTrials.gov database; Describe how industry is navigating US and EU disclosure mandates; Discuss how companies are approaching data sharing expectations

Chair

Robert Paarlberg, MS

Speaker

Panelist
Rebecca J. Williams

Panelist
Marla Jo Brickman, PhD

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Adverse drug reactions (ADRs) are an important part of a product label. In this session, we will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. We will also discuss the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.

Learning Objectives

Discuss how adverse drug reactions (ADRs) are presented in EU and US drug labels; Explain why the qualitative categories of ADR in an EU label and the pooling strategy to obtain ADR frequencies in a US label are inadequate; Describe improved approaches to summarize and present different types of adverse events; Describe key building blocks for a compliant end-to-end labeling system.

Chair

Brenda Crowe, PhD

Speaker

Rational Presentation of Adverse Reactions in Drug Labeling
Ellis Unger, MD

A New Paradigm in Patient Safety: The Importance of End-to-End Labeling and Tracking in Ensuring Pharmacovigilance Compliance
Oliver Steck, MBA

Augmenting Product Labels with Real-World Evidence: Lessons from OHDSI
Patrick Ryan

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-532-L05-P; CME 1.25; IACET 1.25; RN 1.25

The EU pharmacovigilance (PV) legislation has introduced significant changes to the presentation of clinical trial and postmarketing information. Data relevant to the benefit-risk balance of a product must be assessed against the existing standard of care, all of which evolve over time. Documents such as the risk management plan have become increasingly complex and writing them requires strong project management and regulatory skills. This session will describe the experience of managing PV documents and regulatory feedback in this new era, explain why writing for a lay audience is challenging and why it is an important challenge for the pharmaceutical industry to embrace, and will illustrate the challenges of producing, managing, and dealing with evolving benefit-risk assessments with some concrete examples.

Learning Objectives

Describe how to manage the writing of EU-Risk Management Plans including possible challenges and hands-on solutions; Identify the importance of writing for the lay audience along with suggested approaches; Discuss synergies within the preparation of periodic safety documents including how to effectively use them with respect to continuous benefit-risk evaluation.

Chair

Sven Schirp

Speaker

Periodic Reporting in Drug Safety: From Safety Updates to Continuous Benefit-Risk Evaluations
Leonardo Ebeling

The EU-Risk Management Plan from a Medical Writer’s Perspective
Sven Schirp

Writing the Lay Summary (Section VI) of Risk Management Plans: Why and How?
Lisa Chamberlain James, PhD

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

On July 1, 2015, the European Medicines Agency initiated the monitoring of medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances and entering the relevant information into the EudraVigilance database. One of the key objectives of this initiative is to prevent duplication of cases reported by multiple marketing authorization holders (MAHs) for the same active substance through worldwide literature searches. Other intended benefits are to enhance the efficiency of adverse reactions reporting, improve data quality, contribute to resource savings, simplify processes, and support signal detection activities. This session will discuss the need for MAHs to assess the impact of this initiative on their existing process of literature safety report identification, case processing, and expedited reporting.

Learning Objectives

Identify the salient features of the European Medicine Agency's (EMA) medical literature monitoring (MLM) service; Assess the impact on existing global literature search, case processing, and expedited reporting; Identify measures required to align existing pharmacovigilance processes consequent to the implementation of EMA’s MLM service.

Chair

Vineet Kacker, PhD

Speaker

EMA Medical Literature Monitoring Service: Impact on EU Pharmacovigilance
Vineet Kacker, PhD

Authority-Based Medical Literature Monitoring in the EU: Impact on US and Global Pharmacovigilance
Leonardo Ebeling