DIA 2017 Annual Meeting

Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

The objective of this short course is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems

Management and reporting of adverse reactions and signal management

Updates of GVP Module VI •The new EU E2B(R3) ICSR implementation guide

New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA

Updates to the EudraVigilance Access Polic

Who should attend?

This short course is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

Learning Objectives

At the conclusion of this course, participants should be able to:

• Describe recent developments on EU Good Pharmacovigilance Practices guidance
• Examine principles for new literature monitoring and the revised EudraVigilance Access Policy
• Discuss FAQs in signal management
• Identify important aspects in preparing risk management plans and conducting - is something missing here?
• Describe key principles for pharmacovigilance audits and inspections
  
  

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-509-L04-P; CME 6.50; IACET 6.50; RN 6.50

This short course is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Who should attend?

This short course is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

At the conclusion of this course, participants should be able to:

• Discuss how to utilize guidelines and regulatory requirements for clinical trials
• Describe ways to contribute to safety analysis plans
• Discuss the statistical safety analysis process and pitfalls that could occur
• Identify impact of benefit-risk assessment in safety data
  
  

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-17-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this short course, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role play as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

Who should attend?

This course is designed for professionals involved in clinical safety and pharmacovigilance.

Learning Objectives

At the conclusion of this short course, participants should be able to:

• Describe the key milestones needed to create a REMS assessment report
• Identify who and how to engage in the multidisciplinary team required to create the report
• Discuss the type of sections included in various types of REMS assessment reports