Course Description:

Patient safety in clinical trials and the safety of patients taking drugs and biologics already in the US market have become increasingly important, not only to patients, their health care providers, and FDA, but increasingly to the general public and US Congress as news reports relay drug safety problems. FDA regulations and guidance, corresponding requirements in other countries, as well as guidance by the International Conference on Harmonisation (ICH) are continually changing and can be confusing or even, contradictory. In addition, patient advocacy groups, the US Congress, and those unfamiliar with the complexity of drug development are exerting more and more pressure on FDA and sponsors to shorten drug development timeframes yet guarantee no serious adverse drug effects—an impossibility. So what should a sponsor do?

In this two day workshop, participants will learn best practices for meeting FDA and broader real world safety requirements as time and cost efficiently as possible, and how to devise robust systems for collecting and reporting these data. In-class exercises will help attendees write better short safety reports of various types and become aware of the most common problems FDA spots so as to avoid them.

Through case studies, the course will examine best practices to develop for the first time, or to improve, your company’s clinical safety reporting to FDA. Additionally, case studies will demonstrate how your signal monitoring and analysis practices can help or hurt your relationship with FDA, health-care providers, and the general public.

Learning Objectives:

  • Understand what safety information FDA wants and when
  • Know best practices for setting up reliable safety reporting systems internationally, when the US/FDA is just one part
  • Be able to prepare concise and accurate safety reporting documents required at any stage of drug development in the US
  • Understand what FDA is looking for in safety reporting and what are red flags for FDA that you want to avoid

Who will Benefit:

This course is designed for those responsible for developing, maintaining and/or overseeing clinical safety/pharmacovigilance duties or filing clinical trial or marketing application submissions to FDA. The following personnel will benefit from the course:

  • Human Safety/Pharmacovigilance Staff
  • Submissions Medical Writers and Editors
  • Clinical Operations
  • Regulatory Affairs
  • Regulatory Operations
  • Project Managers
  • Data Management
  • US Agents
  • Compliance Professionals
  • Process Owners
  • Document Control Specialists

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time

Meeting the Challenges of the Changing US Clinical Safety Reporting Process – Chronology and Tips from Case Studies

  1. Investigational New Drug (IND) Period
    1. Setting up the safety reporting process
      1. What needs to be reported?
      2. What are the reporting deadlines?
      3. Discussing with FDA events common to the disease process being treated, as opposed to “unexpected.”
      4. What is a serious adverse event (SAE) vs. a suspected unexpected serious adverse reaction (SUSAR) and does the difference matter?
      5. Why is the Investigator’s Brochure (IB) important?
    2. Ensuring your foreign clinical trial safety contractor knows US safety reporting standards and requirements
    3. Creating an efficient Individual Case Safety Report (ICSR) process for international studies that include the US
    4. The FDA annual report/ ICH Drug Safety Update Report (DSUR)
    5. Data Safety Monitoring Board (DSMB) involvement
    6. Importance of harmonizing safety terms prior to data analysis
  2. Marketing Application Period (NDA/BLA)
    1. Querying safety data
    2. Supporting documents, what to do and what not to do:
      1. Narratives
        1. What narratives are required
        2. Content of narratives
        3. Organization of narratives
        4. Responsibility for writing narratives
        5. Examples of narratives
      2. The CTD Summary of Clinical Summary and FDA’s Integrated Summary of Safety (ISS)
      3. Risk Evaluation and Mitigation Strategy (REMS): Do you need one?
      4. The 120-day safety update report
    3. Reporting foreign site safety data in an NDA/BLA
  3. Postmarketing
    1. US reporting requirements:
      1. Periodic Safety Update Report (PSUR)
      2. Periodic Benefit Risk Evaluation Report (PBRER)
      3. PSUR vs. PBRER - submission strategies
      4. FDA’s proposed labeling rule that will affect generic product postmarking safety reporting
    2. Case studies of unusual situations that might arise and how to best handle them
  4. Summary of Day 1/Q&A

FDA Safety Reporting Requirements – Best Practices to Meet Them Efficiently

  1. Changing US Regulatory Requirements and Expectations
    1. Recent FDA changes and clarifications related to clinical safety reporting
    2. Expected future changes
    3. The effects of global harmonization
    4. Role of the US agent reporting safety for a foreign company
  2. IND
    1. Discovering unreported deaths in a sponsor’s prior clinical studies conducted elsewhere in the world, when summarizing those studies for the IND—what to do?
    2. The protocol’s safety reporting section—what to include
    3. Individual case safety reports—how to write them
    4. MedWatch vs CIOMS form—does it matter to FDA which is used?
    5. A separate guideline for complex safety reporting can save time
    6. Sample formats demonstrating best ways to transmit safety data appropriately, accurately, and efficiently
    7. The FDA clinical reviewer’s perspective on Clinical Study Report (CSR) safety narratives - a survey
  3. NDA/BLA
  4. Postmarketing
  5. Summary of Day 2
  6. Seminar Summary/Q&A

Meet Your Instructor

Sandra J. Hecker
RAC, Regulatory Strategist and US Agent - Hecker & Associates, LLC

A biologist/biochemist by training, Sandra Hecker has more than 20 years of experience in drug and biotech development. She was on an Institutional Review Board (IRB) at NIH in the late 1980s, started the Medical Writing (Clinical Submissions) Department at Genentech in 1990, and later worked for several CROs as manager of medical writing/regulatory submissions groups where she collected and developed best, most efficient practices for global safety reporting and regulatory submissions. She later headed regulatory and then drug development groups. Ms. Hecker started her own company in 2001, which advises clients about strategy and requirements for clinical trial applications to FDA and Health Canada, including safety reporting, and represents clients at FDA and advisory committee meetings. She is an US agent for foreign companies filing to FDA. Ms. Hecker’s goal is to create efficient work processes for culturally diverse teams in global drug development, being sensitive to cost constraints typical of small or new drug development companies, and to accommodate ever-changing regional requirements efficiently when working globally.

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