DIA 2018 Global Annual Meeting

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-518-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how the Cardiac Safety Research Consortium’s collaborative, precompetitive approach has significantly advanced the field of cardiac safety in medical product development. Industry, academia, and regulatory perspectives will be provided.

Learning Objectives

Discuss the concept and implementation of Public-Private Partnerships; Recognize the importance of cardiac safety considerations throughout new drug development; Describe new approaches to regulatory science in cardiac safety.

Chair

Rick Turner

Speaker

The Cardiac Safety Research Consortium: Current Accomplishments and Future Goals
Mitchell W. Krucoff, MD

New Approaches to Regulatory Science in Cardiac Safety
Norman Stockbridge

The Comprehensive In-Vitro Proarrhythmia Assay (CiPA)
Philip T. Sager, MD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-519-L04-P; CME 1.25; IACET 1.25; RN 1.25

The session will discuss signal management throughout the lifecycle and how to transition from the pre-approval to the post approval setting. In the post-approval setting, we will concentrate on signal management requirements in EudraVigilance and provide some examples of how companies are addressing the requirements.
The speakers have broad experience and represent the perspectives of CROs, large pharma and small biotech companies.

Learning Objectives

Describe the key elements of a signal management process throughout the lifecycle; Identify the requirements of signal management in EudraVigilance and formulate best practices.

Chair

William Gregory, PhD

Speaker

Experiences with the EVDAS Requirements
Uwe Trinks

From Clinical Trial to Post-Marketing Signal Management: A Continuum
Rosa A. Piccirillo, MD

Latest Initiatives with Signal Detection and Management at MHRA
Mick Foy

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the success of its clinical initiatives, TransCelerate launched its first pharmacovigilance projects in 2017, which are now actively engaging with health authorities and delivering both near-term and long-term value. This session will feature a panel of leaders from TransCelerate’s pharmacovigilance teams, as they discuss the future of pharmacovigilance (challenges associated with globalization, data automation, new PV requirements, etc.) and discuss initiatives that TransCelerate has undertaken to address these challenges.

Learning Objectives

Describe expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges.

Chair

Jose Vega, MD

Speaker

Industry Collaboration to Improve Patient Safety: TransCelerate’s Long-Term Vision to Address Pharmacovigilance Challenges
Jose Vega, MD

Evaluating the Value of Safety Information Data Sources: Gathering Evidence to Illustrate a Hierarchy of Value
Peter Verdru, MD

Interpretation of PV Regulations
Ajay B. Singh, MD

Value of Safety Information Data Sources
Jeremy Jokinen

FDA Perspective
Gerald J. Dal Pan, MD, MHS

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-537-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide an overview of the current state of regulatory inspections – what is their current focus, as well as how inspections align and can vary between regulatory agencies. The MHRA will present a summary on the most common inspection findings as well as guidance on how best to address. Core elements of a comprehensive pharmacovigilance system will be reviewed to detail how one’s organization can achieve and maintain an “Inspection-ready” state. The Pharmacovigilance System Master File (PSMF) is a foundational element that can be invaluable in achieving this goal as it can support the safety governance model to reassure stakeholders the company’s ability to protect patient safety while meeting both global and regional requirements. A detailed review of the key PSMF components and their ability to align with inspectors’ requests will be discussed. Additionally, the session will feature real-world examples of how organizations are able to demonstrate their inspection readiness.

Learning Objectives

Describe the focus of MHRA inspections versus other regulators, such as FDA; Discuss best practices for establishing a fit-for-purpose quality system that meets global PV requirements; Define the core elements for inspection ready; Identify how to utilize the Pharmacovigilance System Master File (PSMF) as an effective inspection readiness tool; List real-world examples of inspection findings and inspection readiness.

Chair

Annette S. Williams

Speaker

Inspection Readiness: How Prepared are Your Systems for Global Regulatory Inspections?
Shelley Gandhi, MS

One Pharmacovigilance System to Satisfy FDA and MHRA’s Inspections
Anil K. Hiteshi, RAC

Inspection Readiness: MHRA Inspectorate Perspective
Joanna Harper

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regulatory agencies have conducted real-world studies of postmarketing safety concerns to inform their regulatory decision-making and explored safety surveillance methods using real-world data. This session will discuss the approach of the FDA, EMA, Health Canada, and PMDA, the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.

Learning Objectives

Describe how regulatory agencies have used real-world data for safety surveillance and studies of post-marketing safety concerns; Discuss future areas of research by regulatory agencies using real-world data, including opportunities for international collaborative research.

Chair

Michael D. Blum

Speaker

Regulator’s Utilization of Real-World Data in Pharmacovigilance Activities
Yoshiaki Uyama, PhD

FDA's Sentinel Program
Michael D. Nguyen, MD

EMA Perspective
Agnès Saint-Raymond, MD

Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?
Rhonda Kropp, BSN, MPH

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will hear from experts involved in digital risk minimization programs. They will describe how, following a Pharmacovigilance Risk Assessment Committee (PRAC) assessment report, a pilot was initiated to assess the feasibility and operational impact of developing and implementing digital additional risk minimization measures. The session will describe how a digital approach can support tool currency, continuous availability, and educational effectiveness. It will also cover aspects of internal vision development, global and local cross-functional collaboration, tool design, regulatory authority interactions, and the critical importance of change management.

Learning Objectives

Identify opportunities for developing digital risk-benefit communications; Describe the organizational aspects of developing digital strategies from the lessons of ongoing programs; Describe the key impacts on people, process and tech in the move to utilise digital approaches for REMS and risk minimization that could be applied to their own organizations.

Chair

Carla Perdun Barrett, PharmD

Speaker

Organizing for Digital Risk Minimization
Helen Edelberg

Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution
Mark Perrott, PhD

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-604-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will present current research and emerging best practices in the field of patient risk communication, including methods for collecting patient input in the design of these communication materials.

Learning Objectives

Identify key elements that are needed to make patient educational materials understandable and actionable for patients in their decision-making process regarding treatment; Examine the value of patient-generated real-world safety data, public hearings, and patient input into the development of risk communication tools.

Chair

Deborah E. Collyar

Speaker

Patient Engagement and Pharmacovigilance: Risk Interventions and Strategic Communications (RISC)
Emily Freeman, PhD, MSc

How Will EU Public Hearings Help with Patient and Public Engagement and How Should the Industry Prepare?
Shelley Gandhi, MS

Can Patient-Generated Real-World Data Illuminate Real World Evidence of Safety Concerns Sooner Than Traditional Sources?
David Blaser, PharmD

How Well Are We Doing Conveying Drug Safety Information to Patients? An Analysis of the Quality of REMS Educational Materials
Meredith Y. Smith

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the past, pharmacovigilance departments have often been limited in the way they interact with other functions within pharmaceutical organizations. The traditional function of the Safety organization has been to prevent harm to patients, and to react to emerging evidence of potential harm. Thus we have been reactive rather than proactive, and tactical rather than strategic.This is now changing. The growing emphasis on health technology assessment in the health care field requires strategic contributions from Safety. And expectations of a more patient-centered approach now mean that we must help patients manage their adverse drug reactions, in addition to simply characterizing and communicating risks. This session will describe how this transformation is taking place, resulting in a Safety organization that is a full strategic partner in development, and a key supporting function for commercialization. Strong, cross-functional safety governance is essential for effective decision making; means for assessing and improving safety governance maturity will be presented.

The session will also describe the evolving role of the safety statistician in helping multidisciplinary safety teams to think more quantitatively, and to improve the conversations we are having about safety evaluation during drug development.

Learning Objectives

Identify the forces in the healthcare system which are producing strategic changes in the safety organization; Assess the maturity of safety governance in your organization and identify opportunities for improvement: Describe how to form more effective partnerships with safety statisticians to drive the clinical decision-making process with medical judgment that is informed and supported by quantitative assessments of the data.

Chair

Alan M. Hochberg

Speaker

Evolving the Strategic Framework for the Safety Department
Alan M. Hochberg

Building Better Governance: The Maturity of Safety Governance Models and Considerations for Organizations
Ellenie Nichols, MEd

Multi-Disciplinary Approach for Successful Collaboration: Improving Conversations to Achieve Impact in Drug Development
Amit Bhattacharyya, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The session will provide an overview of the current pharmacovigilance landscape and where the industry stands on automation versus manual processes with respect to adverse event processing, assessing, reporting and signaling. Functional areas will then be presented where companies can employ simple to sophisticated means to automate many of the resource intensive processes that will result in better consistency, higher quality and improved compliance.

Learning Objectives

Identify functions or processes that could benefit from improvements within their own pharmacovigilance practice especially through methods of automation; Explain how companies have successfully automated many aspects of the PV process and the benefits as well as liabilities such an automation can bring.

Chair

Axel Hagel

Speaker

Data Visualization and Analytics for Medical Monitors: Tech Adoption and Best Practices
Masha Hoffey, MS

Signal Detection in Social Media: Feasibility Assessment of Methods
Neal Grabowski, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-623-L04-P; CME 1.25; IACET 1.25; RN 1.25

While the product label represents the primary source of information about a medicine’s risks, numerous other types of risk communication measures have been used or required by regulatory authorities to date, including Dear Healthcare Provider Letters, Medication Guides, educational brochures, monographs, reminder and/or alert cards, and checklists. Such materials are typically intended for a diverse audience (e.g., healthcare professionals, patients, informal care providers, general public) and for use in a diverse array of settings, ranging from hospital and outpatient clinics to home-based. Increasingly, regulatory authorities are seeking to incorporate new learnings from the science of risk communication to support more effective tools and methods for reaching these audiences, including patient-centered approaches, shared decision-making techniques, electronic medical records, and other digital-based forms of communication.
The purpose of this session is present highlights from recent risk communication initiatives at the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), and to illustrate how learnings from the emerging field of implementation science can be used to enhance the effectiveness of risk communication by both regulators as well as sponsors.

Learning Objectives

Describe recent efforts by a major regulatory authority (the European Medicines Agency) to improve the quality of therapeutic risk communication via partnership and engagement with patients and healthcare professionals; Identify how to implement therapeutic risk communication programs; Discuss new types of risk communication tools that the FDA has developed for sponsors to use when communicating medicinal product risks to healthcare professionals and patients.

Chair

Meredith Y. Smith

Speaker

Engaging Patients and Healthcare Professionals in Evaluating Risk Minimization Measures: How Can Regulators Best Listen to Medicine Users for Improved Regulatory Decision Making and Risk Communication
Juan Garcia-Burgos, MD

New Risk Communication Approaches for Patients: The FDA's Benefit-Risk Counseling Framework and Other Tools
Michael S. Wolf, PhD, MA, MPH

Prescription Medication Information and Adherence: New Research and Future Directions
Marina Serper, MD, MS

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-638-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of its REMS integration initiative under the Prescription Drug User Fee Act V, the FDA committed to improving the integration of risk evaluation and mitigation strategies (REMS) into the healthcare system. A designated team (the Design and Standardization Work Group) was established to identify best practices to incorporate into REMS design, as well as appropriate ways to standardize REMS tools and integrate REMS into the healthcare delivery system. Results of this workstream have important implications for how industry designs its REMS programs moving forward as well as for the efficiency of the healthcare system.
This session will discuss how it remains unclear as to how to accomplish this goal from a practical perspective.

Learning Objectives

Describe the nature of FDA’s commitment to reduce the burden of REMS on the healthcare system and to provide an update on the design and standardization workstream; Discuss a REMS program that was successfully integrated into the clinical workflow; Identify policy options for integrating REMS into the healthcare system.

Chair

Meredith Y. Smith

Speaker

An Update on the FDA's Design and Standardization Workstream in Regard to Integrating REMS Into the Health Care System
Gerald J. Dal Pan, MD, MHS

Factors Impacting Selection of Risk Minimization Interventions
Sarah A. Frise

What are the Policy Options for Facilitating the Integration of REMS Strategies into the Healthcare System?
Gregory Daniel, PhD, MPH, RPh

Component Type: Session
Level: Intermediate
CE: IACET 0.50

Seating is limited
As for the Qualified Person for Pharmacovigilance in industry (QPPV), Competent authorities and EMA could ask patients’ and consumers’ organisations to appoint an official contact person for pharmacovigilance. Although this contact person for patients has no legal obligation and is not mentioned in the legislation it is very much needed to maintain trust and confidence in marketed medicines. This Contact Person, ‘the Vigil’, would be trained on how pharmacovigilance is organized in Europe and in Member State of interest, and would be the liaison between members of an organization or users of social networks, and national or European regulatory authorities, possibly also for industry (as a second step). A registry of Contact Persons will list all volunteers appointed by their national authorities or EMA. The Vigils will benefit from training by national authorities, EMA, and other patients’ training programmes. Examples of successful engagement of patients in pharmacovigilance will be collated and analyzed. An action plan has been defined and written engagement sought from interested parties. This will include a Code of Practices, a reflection on legal status, and core competencies for a job description with enough flexibility for all types of patients’ organisations. A future aim is to create a sustainable structure to host the initiative and there are ongoing discussions with CIOMS as part of a possible group examining patient’s role in pharmacovigilance.

Learning Objectives

Describe the role and training needed for named patient for PV; Debate pros and cons of named patient for PV and identify opportunities that this role can produce; Identify how to get involved and help promote this initiative.

Chair

Brian Edwards, DrMed

Speaker

Patient Engagement in Pharmacovigilance
Herve Le Louet

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-674-L04-P; CME 1.25; IACET 1.25; RN 1.25

Prescription opioids can be used to treat moderate-to-severe pain, such as pain following surgery or injury, in health conditions such as cancer, and in chronic, non-cancer conditions such as back pain or osteoarthritis. More than 25 million Americans suffer from daily chronic pain, and prescription opioid therapy has been instrumental in helping patients manage their symptoms and achieve a better quality of life. However, it is estimated that more than 2 million Americans have opioid use disorder (OUD), and that millions more misuse opioids, taking these medications longer or in higher doses than prescribed. The problem has reached a level of crisis, as an average of 115 Americans die each day from an overdose of opioids, either prescription or heroin. According to CDC statistics, the number of overdose deaths involving opioids increased five-fold from 1999 to 2016, driven largely by prescription opioids.

These alarming increases in opioid-related harms have mobilized the US health system to implement strategies to support safe use and appropriate prescribing behaviors. This session will examine the framework and current strategies for a well-balanced approach aimed at reducing the supply of opioids vulnerable to misuse and mitigating risks through more judicious prescribing. Panelists will discuss the critical need and ways to assess the impact of these strategies on patient health outcomes and public health in order to avoid creating barriers to appropriate treatment for both acute and chronic pain.

Learning Objectives

Describe strategies to promote the safe use and prescribing of opioids within a framework balancing safe prescribing and appropriate pain management, risk mitigation, and patient access; Discuss how strategies can be implemented and determine how success may be defined and measured.

Chair

Sidney H. Schnoll

Speaker

Safe Use of Opioids: FDA Perspective
Gerald J. Dal Pan, MD, MHS

Opiates: A Patient Experience
Alton Johnson, PhD, RPh

Clinician/Drug Development Perspective
Veeraindar Goli

Prescribing Opioid Medicines for Patients
Daniel P Alford, MD, MPH, FACP