DIA 2020 Virtual Global Annual Meeting

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-064-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

This half day short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, how local labeling changes and regulatory requirements may have an impact on Company Core Data Sheet (CCDS). In addition, it will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments

Learning Objectives

• Discuss the concept and use of CCDS;Analyze with the detailed content of CCDS;Discuss knowledge of core labeling implementation and deviations; Identify options to bridge different local/regional requirements in the CCDS; Examine the potential impact of CCDS on the company, e.g. tracking, deviation management.

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 02086-0000-20-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.


Learning Objectives

Describe the transition from traditional methods of data analysis to visual approaches;Identify life science data using one or more data visualizations;Assess the strengths and limitations of various graphical techniques;Explain the “data story” of numerous clinical research, examples using data visualization techniques.

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session we will discuss ongoing initiatives in the field of electronic labeling and look ahead to their potential impact on the future of digital health, with a particular focus on patient product information in the US, EU, Japan, and Asia. This session will also discuss how different approaches to electronic labeling may converge across regions, driving a new patient-centric focus to product information.

Learning Objectives

Discuss how emerging trends for electronic labeling are impacting risk communication across the US, EU, Japan and Asia; Describe the challenges of provision of patient product information in the future; Discuss approaches to improving health literacy and adherence to patient labeling; Discuss the possibility of convergence of electronic labeling standards to drive patient centricity across regions.

Chair

Rie Matsui, RPh

Speaker

PMDA’s Updates for Electronic Labeling Initiative and Patient-Centric Labeling in Japan
Junko Sato, PhD

Electronic Product Information (ePI) in the EU: Key Principles and Beyond
Elizabeth Scanlan, PhD, MSc

Electronic Labeling in the US / Canada and A Global eLabeling Vision
Khyati Roberts, RPh

Dynamic Landscape in Asia for Electronic Labeling and Patient Labeling
Rie Matsui, RPh

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will highlight progress to date in identifying metrics to assess patient involvement in drug development and drug safety, and the current challenges to, and benefits of, achieving a more patient-centric culture within the pharmaceutical industry. Perspectives on this topic will be provided by representatives from IMI-PARADIGM, industry, the patient advocacy sector, and the US FDA. Join the DIA Patient Engagement Community for a follow up round table discussion (session #216 L-RT) on Tuesday, June 16, 10:45AM - 11:30AM.

Learning Objectives

Discuss how to use a framework to guide selection of appropriate patient-centricity metrics for use within a pharmaceutical company; Describe the types of metrics that have been developed to date to measure patient involvement in drug development, including drug safety; Identify key challenges to implementing patient-centricity metrics within a pharmaceutical company and identify specific strategies to overcome those barriers.

Chair

Mariette Boerstoel-Streefland, MD, MBA, MS

Speaker

FDA Update
Robyn Bent, MS, RN

Industry Update
Katherine Capperella

Policy Update
Elisabeth Oehrlein, PhD, MS

What Frameworks and Metrics Exist for Measuring Patient-Centricity in Drug Development and Drug Safety
Tjerk Jan Schuitmaker, PhD, MSc

Component Type: Forum

Join DIA Patient Engagement Community for a round table discussion tied to session #201 L: Patient-Centricity: How do we Measure Progress in Involving Patients in Drug Development and Drug Safety? (Tuesday, June 16, 8:00AM - 9:00AM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host. To include special guests from the session: Mariette Boerstoel-Streefland, Robyn Bent, Katherine Capperella, Elisabeth Oehrlein.

Chair

Mary Murray, MBA, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-651-L04-P; CME 1.00; IACET 1.00; RN 1.00

Pharmacovigilance (PV) transformation is top-of-mind for safety leaders. Internal and external stakeholders demand fresh thinking regarding operating models and capabilities for PV organizations. Forward-thinking leaders are pulling on multiple strategic levers, from bringing in new ways of thinking to acquiring a different type of talent to implementing game-changing technologies. The pharma companies that will be the most competitive in the future are the ones that are able to quickly transform.

Learning Objectives

Discuss how to transform their PV organizations into more strategic and elevated operating models; Describe how to adapt agile methods and approaches to the safety-critical, compliance-driven environment of healthcare;Identify how to apply the agile approach to areas other than software development.

Chair

William Gregory, PhD

Speaker

Workload! What Can We Pull Out of Our Pharmacovigilance Toolkit to Spell Success in 2030?
William Gregory, PhD

The Secret Ingredients to Reinventing Drug Safety Organizations
Kemi Yusuf, MBA, PMP

Agility and Safety: Are They Compatible?
Alan M. Hochberg

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-632-L04-P; CME 1.00; IACET 1.00; RN 1.00

Evaluation of risk evaluation and mitigation strategies programs in the US or additional risk minimization measures (aRMM) in the EU is required by regulatory bodies in their respective jurisdictions, though the approach, timing, requirements, and available guidance varies. Due to regulatory and cultural differences in global risk minimization practices, successful evaluation of risk minimization programs can be challenging. This forum will share views from varying stakeholder perspectives in the US and Europe for consideration in regulatory discussion, design, and implementation of these programs. Special consideration for practical implementation across different geographic regions in light of a pandemic to meet different regulatory requirements will be discussed. Practical challenges to evaluation implementation (e.g. identification of target population, controlling for selection bias, design options for process and outcome measures and cultural adaptation and consideration—will be discussed. Areas of benefit-risk management and communication will include: Rigorous approaches for evaluation, and practical considerations for planning for evaluation of risk minimization tools Presenters will share examples from their experiences for consideration in the planning, design, and implementation of evaluation of risk minimization programs, with focus on global implementation.

Learning Objectives

Identify at least three design considerations for evaluation of risk minimization programs that should not be compromised despite challenges to resource and logistics; Recognize at least two practical considerations in design of evaluation of a global risk minimization program in light of a pandemic.

Chair

Alicia Gilsenan, PhD, MS, RPh

Speaker

Considerations for REMS Evaluation from US Regulatory Perspective
Cynthia LaCivita, PharmD

Special Considerations for Evaluation of Additional Risk Minimization Measures: European Perspective
Annalisa Rubino, DrSc, PhD, MSc

Practical Considerations for Global Evaluation of REMS and aRMM from Industry Perspective
Meredith Smith, DrPH, PhD, MPA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-633-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session describes CDER initiatives to bring consistency and improve quality of pre-market safety assessments.

Learning Objectives

Describe various new drug review modernization initiatives related to pre-market safety assessment happening at CDER; Discuss the reasons for the change and their impacts on pre-market safety assessment.

Chair

Vaishali Popat, MD, MPH

Speaker

The FDA Medical Queries Project: This Will Significantly Change How We Do our Safety Signal Detection
Scott Proestel, MD

The Standard Tables and Figures Visualization Project
Preeti Venkataraman, MD

Data Integrity Project
Vaishali Popat, MD, MPH

Planning for Key Risks That are Undertaken Prior to Confirmatory Trial Initiation
Mat Soukup, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-682-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH safety topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway.

Learning Objectives

Discuss the role of ICH Safety topics in harmonizing standards for more efficient pharmaceutical development and registration;Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development.

Chair

Amanda Marie Roache, MS

Speaker

Regulatory Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
John Leighton, PhD

Industry Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Daniel M Lapadula, PhD

ICH S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
Douglas Keller, PhD

ICH E14/S7B Questions and Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential
David Strauss, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the principles in the detection, characterization and risk assessment of DILI in clinical trials and post-marketing, liver safety biomarkers and DILI risk stratification, risk minimization measures and risk communication.

Learning Objectives

Describe the accurate identification, assessment, and management of DILI risk; Discuss a new initiative to tackle this problem undertaken by an international working group of industry, academic, and regulatory experts; Examine the findings by CIOMS for best practices in DILI risk assessment and& management and biomarker development in clinical trials and the post-market.

Chair

Mark I. Avigan, MD

Speaker

Introduction to the CIOMS Working Group
Mark I. Avigan, MD

Goals, Initiatives, and Context of the 2020 DILI Report
Herve Le Louet, DrMed, DrSc, MD, PhD, MS

Principles in the Detection, Characterization, and Risk Assessment of DILI in Clinical Trials
Arie Regev, MD

Steps Towards the Identification and Utilization of Liver Safety Biomarkers
Robert J. Fontana, MD

Best Practices in Postmarket DILI Risk Assessment, Risk Minimization, and Communication
Walter Straus

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-692-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss a validation framework that extends existing guidance, incorporates best practices from other industries and member companies, and promotes discussion of key considerations to achieve early alignment on validation requirements in advance of future guidance. The ICSR processing workflow is the use case for evaluating intelligent automation opportunities due to its logical progression of process steps, highly manual nature, high volume, and inherent quality risks of errors and operational inefficiencies.

Learning Objectives

Describe the current technology landscape in PV, particularly focusing on the ICSR process; Discuss intelligent automation opportunities within the ICSR process using an industry survey results and online ICSR process map; Identify considerations for validating intelligent automation technologies in pharmacovigilance to promote inspection readiness and inform third party development.

Chair

Neal Grabowski, MBA, MS

Speaker

Case Study
Kate Gofman, MD, PhD

Case Study
Oeystein Kjoersvik, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-693-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the clinical consequences of the immunogenicity of 1) biologics for autoimmune diseases, 2) biologics for oncology, and 3) biosimilars.

Learning Objectives

Identify the immunologic basis for adverse events caused by biologics used for autoimmune and oncology indications; Recognize and manage the clinical consequences of immunogenicity; Discuss how to study the immunogenicity of biologics and biosimilars and manage the clinical risk.

Chair

Michael Blum, MD, MPH

Speaker

Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity
Vibeke Strand, MD, FACP

Monitoring and Assessment of the Impact of Immunogenicity on Clinical Safety for Oncology Biologics in Development
Dina Tresnan, DVM, PhD

Immunogenicity in the Biosimilars Space
Daniela Verthelyi, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-694-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will examine current challenges to the use of digital approaches to risk minimization, and explore opportunities for overcoming them to facilitate their wider adoption. Challenges and opportunities will be assessed from the perspectives of 1) regulators, including representatives from both the US and the European regulatory authorities; 2) industry sponsors at the global headquarters who plan the risk minimization strategy; and, 3) local safety officers who are responsible for coordinating the implementation of the risk minimization measures, typically in conjunction with healthcare professionals at the local country level.

Learning Objectives

Describe the state of the art in terms of the use of digital approaches for therapeutic risk minimization purposes; Discuss challenges and constraints faced by sponsors and regulators in terms of adopting digital approaches to risk minimization; Identify at least two steps that can be taken to further advance adoption of digital technologies for risk minimization purposes.

Chair

Meredith Smith, DrPH, PhD, MPA

Speaker

Industry Sponsor Perspective: What are Digital Risk Minimization Measures? What are the Challenges Sponsors Face in Developing Them? How Can we Overcome Them?
Meredith Smith, DrPH, PhD, MPA

Regulatory Perspective: Opportunities and Challenges for Adopting Digital Risk-Minimization Measures
Gita Toyserkani, PharmD, MBA

Regulator Viewpoint
Fakhredin Sayed Tabatabaei, MD, PhD

Local Safety Officer Perspective: What Are the Advantages and Challenges to Implementing Digital Approaches to Risk Minimization at the Local Country Level and How Can They be Addressed?
Carla Perdun Barrett, PharmD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-732-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the results of a recently conducted industry-wide survey on the use of quantitative benefit-risk assessment (qBRA) methods within life science companies. In particular, it will describe whether and to what extent such methods are being utilized, what are the types of qBRA methods being utilized, challenges to implementing qBRA within these organizations, and strategies for overcoming those challenges.

Learning Objectives

Describe when, why and to what extent qBRA is being adopted within different life science companies to inform decision making; Describe the range of frameworks and methods being utilized within life science companies to implement qBRA; Identify the challenges to introducing qBRA within life science companies and ways that these have been overcome, including factors to facilitate successful implementation.

Chair

Meredith Smith, DrPH, PhD, MPA

Speaker

When, Why, and to What Extent qBRA is Being Adopted Within Different Lifescience Companies to Inform Decision Making?
Kevin Marsh, PhD, MSc

What Are the Types of Benefit-Risk Assessment Frameworks Being Used Within the Pharmaceutical Industry Currently and What are the Range of qBRA Methods Being Employed?
Brett Hauber, PhD

What Are the Challenges to Introducing qBRA Within Lifescience Companies and Ways that These Have Been Overcome?
Rachael L. DiSantostefano, PhD, MS

Component Type: Forum

Component Type: Session
Level: Basic

From rapidly changing local regulatory requirements to the urgency of informing local plans with emerging benefit-risk intelligence…there is intense spotlight on transforming the Local Safety Officer role.

Learning Objectives

Discuss the new skills and responsibilities that Local Safety Officers need to elevate the value they deliver within their local countries; Describe ways to maximize the talent in these roles and utilize their skills in positioning PV as a strategic advantage locally.

Chair

Calvin John Johnson, MSc

Speaker

Successful Profile of the Future Local Safety Officer
Calvin John Johnson, MSc

The Local Safety Officer Role in Action
Heidi Levens, MSc

The Local Safety Officer role from a Regulator's perspective
Kiernan Trevett, MSc

Component Type: Forum
Level: Intermediate

MedDRA terms are often used de novo in safety information, but certain related terms appear in unrelated parts of the hierarchy. CIOMS is developing principles to facilitate global convergence of various independent safety communication initiatives.

Learning Objectives

Describe rationale for the initial stratification of safety information by CIOMS into three categories; Discuss the importance of regulatory mandates to simplify communication of medical concepts in safety information; Explain goals of CIOMS in developing consensus principles for grouping terms in safety information.

Chair

William Gregory, PhD

Speaker

Background and Rationale for MedDRA Labeling Groupings
William Gregory, PhD

Near-Synonymous MedDRA Preferred Terms
Scott Proestel, MD

CIOMS Working Group Effort to Develop MedDRA PT Label Groupings
Sonja Brajovic, MD

An Industry Approach to Applying MedDRA in Labeling
Ilona Grosse-Michaelis, DrMed, MD

Component Type: Workshop
Level: Advanced

Informed consent involves information, comprehension, and voluntariness. Effective communication requires thoughtful methods beyond “lay language” translation. We will review novel approaches; participants will create ICD risk sections.

Learning Objectives

Recognize commonly-used patterns of communicating risk/benefit language that may not be patient-friendly; Demonstrate the synthesis of risk information that would be appropriate for an informed-consent discussion that incorporates best practices in patient-friendly communication.

Chair

Lindsay McNair, MD, MPH, MSc

Speaker

Facilitator
Joan Affleck, MA, MBA

Component Type: Session
Level: Intermediate

FDA has several decades of experience and learnings in facing an opioid crisis of enormous proportions. Although only one participant in the battle to turn the tide of morbidity and mortality, the Agency has been deeply engaged in ascertaining how to best use regulatory science to do so, and particularly how to scientifically gauge the impact of regulatory interventions and policy. Traditional pharmacoepidemiology served as a starting point, but FDA has had to adapt and identify new sources of data and methods of analysis to fully contemplate the epidemic and its roots, activities essential to ending it. Dr. Dal Pan has led the Office of Surveillance and Epidemiology in these activities from the beginning, and will share its top lessons, some of which have turned traditional pharmacovigilance and epidemiology on its head.

Learning Objectives

Describe the pathways to abuse/misuse of prescription opioids and related adverse outcomes; Describe the data resources for descriptive epidemiology and abuse signal detection; Describe regulatory and policy interventions used to combat the opioid epidemic.

Chair

Sandra L. Kweder, MD

Speaker

FDA Update
Gerald J. Dal Pan, MD, MHS

MHRA Update
June Munro Raine, MD, MSc, FRCP

Policy Update
Cristian A Herrera, MD, MBA, MSc

EMA Update
Pavel Petrov Balabanov, MD, PhD

Component Type: Forum
Level: Basic

A panel of distinguished leaders in healthcare, consumer advocacy, and regulated industry will discuss how COVID-19 has broken the paradigm for data sharing as it pertains to drug development and drug safety research – and take the audience through an exercise to define shared value to move forward with a renewed commitment to more open data sharing with public health at its core.

Learning Objectives

Recognize barriers to data sharing for the purposes of drug safety and pharmacovigilance; Identify shared goals across consumer, health system, government, and industry stakeholders; Outline a platform for the responsible and collaborative engagement in data sharing and linkage for the purpose of drug safety and pharmacovigilance.

Chair

Carla Rodriguez-Watson, PhD, MPH

Speaker

Panelist
Sarah Greene, MPH

Panelist
Carlos Garner, PhD

Panelist
Deven McGraw, JD, LLM, MPH

Component Type: Session
Level: Intermediate

Patient preference studies are an increasingly important means of assessing patient perspective on the benefit-risk trade-offs and the importance of properties of medical treatments. Regulator, industry, academic, health technology assessment, and patient –stakeholders are conducting these studies to inform development, regulatory, healthcare and reimbursement decisions across the medical product lifecycle. To enable well-designed studies and informative results, it is important to understand when patient preference studies best inform decision making and the needs and concerns of stakeholders using the results. Additionally, understanding methods of use with clinical trial data enables clear communication and appropriate application of results to inform decision making. This session will present a critical assessment of results from the first phase of PREFER, an Innovative Medicines Initiative (IMI) research project developing recommendations on how and when to use patient preference study for informing medical product development. It will describe three broad classes of approaches to applying patient preference results to clinical trials/data and key trade-offs between these approaches. The session will also demonstrate practical use of patient preferences in regulatory applications at FDA CBER, including roles in osteoarthritis, sickle cell anemia and type I diabetes islet cell transplant.

Learning Objectives

Identify where in the medical product lifecycle (MPLC) patient preference studies can best inform decision making and related stakeholder needs and concerns; Describe different approaches, with related advantages/disadvantages, for applying preference study results for informing MPLC decisions; Describe current and future FDA CBER regulatory applications for preference studies.

Chair

Kristin E Bullok, PhD

Speaker

Critical Assessment of PREFER's First Phase Results: Methods and Challenges
Rosanne Janssens, MSc

Applications of Patent Preferences Studies in Drug Development: How Preference Data Can Inform Decisions
Bennett Levitan, MD, PhD

Capturing Patient Preferences to Inform Regulation of Medical Products
Telba Irony, PhD

Component Type: Session
Level: Intermediate

As the expectations for an organization’s pharmacovigilance system and the supporting quality management system rise, so does the scrutiny of them through inspections by regulatory agencies. Inspections are a necessary check of the systems’ effectiveness, but can be a source of anxiety. Understanding expectations in the inspections not only provides confidence for the actual inspection event itself, but also supports excellence in activities that are conducted every day. This session will provide insight on approaches to inspection preparation and management, recent areas of inspection focus, and ideas on improving quality practices with the objective of leading to a continuous state of inspection readiness.

Learning Objectives

Describe key areas of current inspection focus; Identify best practices for preparation and management of inspections; Recognize how lessons from inspections can inform practices in your organization and enhance day-to-day execution; Discuss how obtaining and sharing knowledge about inspections and inspection outcomes can support a culture of quality across the organization.

Chair

David William Fryrear, MS

Speaker

Trend of Findings in Pharmacovigilance Inspections Conducted by Different Health Agencies
Bhawna Rastogi, DrMed

UK Pharmacovigilance Inspections: Inspection Readiness and Recent Inspection Findings
Anna Adams, PhD, MSc

Component Type: Session
Level: Intermediate

Safety for subjects participating in clinical trials is paramount. Regulatory reporting requirements that are in place around the world facilitate the timely notification of regulatory authorities, sponsors, investigators and ethics committees to ensure that that emerging risks are identified swiftly and that trial subjects are protected. Once a product is granted authorization, pharmacovigilance requirements apply to ensure patients are protected and, if interventional studies are ongoing, clinical trials requirements continue to apply to ensure protection for trial subjects. This session will look at novel approaches to efficiently fulfilling safety reporting requirements for clinical trials. The session will also examine the interfaces between pharmacovigilance and clinical trials, and how strong relationships between pharmacovigilance and clinical functions can achieve a more proactive approach to protecting both patients and trial subjects.

Learning Objectives

Describe the interfaces between pharmacovigilance and GCP; Identify tools for building practical relationships between pharmacovigilance and GCP to better protect patients and trial subjects; Recognize effective processes for ensuring timely safety reporting to regulatory authorities and other concerned stakeholders to ensure trial subjects are protected in real-time.

Chair

Anna Adams, PhD, MSc

Speaker

The Need to Focus on the GCP/PV Interface to Improve Compliance, Data Integrity, and Confidence in Inspection Readiness
Shelley Gandhi, MSc

Precision Global Safety Reporting in Clinical Trials According to Local Rules and Industry Standards
Steven Beales

Component Type: Session
Level: Intermediate

Oversight is essential to assure that pharmacovigilance processes remain in a state of control, responsibilities are being performed as assigned, and that the quality management system supporting pharmacovigilance is effective. Effective oversight is an ongoing monitoring activity that looks at processes end-to-end, verifying that they are designed well and executed in a consistent and systematic way. Feedback loops from oversight activities are essential to drive continuous improvement. Oversight approaches must advance to keep up with the ever-increasing complexity of pharmacovigilance activities as well as the new opportunities presented by technology. Quality assurance auditing, the classic oversight tool, is evolving to leverage technology to be both more effective and efficient. Continuous evaluation of process performance, end-to-end through communication of safety information via labeling, is critical to assuring the correct linkages and that the process is always completed as expected. Assessing the external landscape and using the intelligence obtained provides and important way to check that the pharmacovigilance system is complete and stanards are aligned with current expectations. This session will cover how different approaches can contribute to a robust oversight model across the continuum of pharmacovigilance activities.

Learning Objectives

Recognize innovations in quality oversight through remote audit techniques; Describe how regulatory intelligence can be leveraged as a strategic compliance advantage; Identify how the Company Core Data Sheet (CCDS) can be manage to assure that safety information is consistent and complete globally.

Chair

David William Fryrear, MS

Speaker

Robust Regulatory Intelligence: A First Step Towards Compliance
Marina Suvakov, MS

Quality Oversight of Pharmacovigilance Processes by Technology Driven Remote Audits
Gaurav Shah, PharmD, PhD

CCDS or Local Labeling, a Chicken-and-Egg Situation? The Dilemma of the Product Reference Information Across the Consistency
Luca Cariolato, PhD, MSc