Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently

• 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

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.