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: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-576-L05-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to understand, develop, and implement the review/reporting process for events considered anticipated based upon the disease under study which is an important new procedure within clinical development. Attendees will also learn through the examination of case studies clarifying issues leading to uninformative safety reporting.

Learning Objectives

Describe barriers to implementation of the FDA Rule; Clarify the FDA Rule and guidance in order to reduce the number of uninformative safety reports; Recognize the end to end process of the aggregate review and reporting of Anticipated Events; Convert the knowledge of the process into a tangible approach for adoption; Identify how to guide an organization to develop and implement a process; Identify opportunities for improving the quality and efficiency of IND safety reporting processes.

Chair

Robert (Mac) Gordon, MS

Speaker

Using Case Studies to Facilitate Implementation of the FDA Rule for IND Safety Reporting
Marsha Millikan

FDA Perspective
Jonathan P. Jarow, PhD

One Company's Approach to Developing and Implementing an Anticipated Events Review Process
Robert (Mac) Gordon, MS

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

A multiperspective, practical look at incorporating social listening into pharmacovigilance practices—including challenges, knowledge and guidance gaps, regulatory guidance, and recent research as well as experiential findings from both pharma and academia. Come hear some very up-to-date and practical learnings from social media in pharmacovigilance and be challenged to rethink some preconceptions about it.

Learning Objectives

Discuss current challenges and gaps in use of social media for pharmacovigilance including patient privacy, regulatory guidance, legal and reporter identification as global issues; Explain how some pharmaceutical companies have overcome some of those challenges to collect and analyze social media data to augment current postmarketing pharmacovigilance measures and where value has been found; Describe some findings from recent research efforts and data collection methods.

Chair

Laurie S. Anderson, PharmD

Speaker

Current Gaps and Challenges in Pharmacovigilance with Respect to Social Media
Lalitha P. Aiyer, MD, MBA, MS

A Real-World Look at Mining Social Media for Adverse Events: Impact of Regulatory Definitions and Methods
Michael A. Ibara, PharmD

Real-World Use of Social Listening for Pharmacovigilance Currently in the Pharmaceutical Industry
Lorrie Schifano, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

Measuring effectiveness of risk minimization activities is an essential part of risk management, but doing it can be challenging. Experts will discuss requirements in different regions, CIOMS IX, possible methodologies, and the challenges.

Learning Objectives

Describe the importance of measuring the effectiveness of risk minimization activities and the requirements in different regions; Discuss the different methodologies for measuring effectiveness; Discuss opinions from regulatory, industry, and contract research on the challenges of measuring effectiveness.

Chair

Stella C.F. Blackburn

Speaker

Risk Management Plans and Risk Minimization: What Have We Learned and Where Is It All Going?
Shelley Gandhi, MS

CIOMS IX and the Theory of Assessing Effectiveness
Stella C.F. Blackburn

Additional Risk Minimization Measures for EU Centrally Authorized Products, 2006-2014: A Qualitative and Quantitative Review
Annalisa Rubino, PhD

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

On September 29, 2010, FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information in order to reduce the number of uninformative reports distributed by sponsors. An audit of randomly selected expedited safety reports submitted to FDA’s Office of Hematology and Oncology Products (OHOP) in 2015 revealed that the majority of submitted safety reports were uninformative. Submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Representatives from OHOP will present the current state of safety report submissions and efforts to modernize safety reporting.

Learning Objectives

Recognize the current state of safety report submissions to FDA’s Office of Hematology and Oncology Products (OHOP) based on a 2015 audit of safety reports as well as actions that OHOP has taken to guide sponsors to submit informative safety reports; Describe processes and procedures that the pharmaceutical industry has implemented to improve expedited safety reporting practices for hematology and oncology products; Describe OHOP-led initiatives to modernize safety reporting submission.

Chair

Tamy Kim, PharmD

Speaker

FDA Perspective
Suranjan De, MBA, MS

A Large Pharma’s Experience with Implementing the FDA Final Rule on Expedited IND Safety Reporting
Nina Stuccio, DO

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide an overview of ongoing initiatives at government, industry, and academic sites on leveraging Big Data for adverse drug reactions detection.


Learning Objectives

Discuss how Big Data can improve the detection of adverse drug reactions; Identify the data sources that will likely to be part of the Big Data paradigm envisioned for pharmacovigilance; Define the strengths, limitations, and challenges associated with the use of each of the identified data sources for improving the detection of adverse drug reactions.

Chair

Rave Harpaz, PhD

Speaker

Harnessing Scientific Literature Reports for Pharmacovigilance: FDA Perspective
Alfred Sorbello, DO, MPH

Maximizing Data Sources for Signal Detection: Pharmaceutical Company Perspective
Amy Purrington, MD

Social Media Mining for Public Health Monitoring and Surveillance
Graciela Gonzalez Hernandez, PhD