EXPEDITED REPORTING TIMELINES (7/15 DAY RULES)

Expedited Reporting Timelines (7/15 Day Rules)

In pharmacovigilance (PV), time is critical. Regulatory agencies require serious adverse events (SAEs) and unexpected drug-related reactions to be reported within strict timelines — typically 7 days for fatal or life-threatening events and 15 days for all other serious events..

The EXPR: Expedited Reporting Timelines program equips learners with the knowledge to understand, track, and comply with expedited reporting requirements across global health authorities. This training is essential for ensuring patient safety and maintaining compliance with international pharmacovigilance regulations.

SIP – Self-Paced Online with Support

1. Course Duration: 3 weeks (80 hours)
2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).

   By the end of this course, learners will:

1. Understand regulatory requirements for expedited reporting (FDA, EMA, ICH-E2B).
2. Learn the 7-day and 15-day reporting rules for SAEs and SUSARs (Suspected Unexpected Serious Adverse Reactions).
3. Identify case triggers that mandate expedited reporting.
4. Gain knowledge of report formats: CIOMS I forms, MedWatch, E2B submissions.
5. Develop skills to track case receipt dates vs. reporting due dates.
6. Explore global differences in expedited reporting timelines (e.g., FDA, EMA, Health Canada, MHRA).
7. Understand the role of quality control and compliance monitoring in reporting.
8. Review real-world case examples of expedited submission workflows.

1. Drug Safety / PV Associates responsible for case processing and reporting.
2. Clinical trial professionals handling SAE submissions to sponsors and regulators.
3. Regulatory Affairs staff overseeing compliance with expedited reporting timelines.
4. Career changers seeking specialized PV skills to enhance job-readiness

1. Master the 7-day and 15-day expedited reporting rules.
2. Be able to classify and process cases requiring expedited submission.
3. Improve compliance with global PV regulatory standards.
4. Gain readiness for roles such as PV Associate, Case Processor, Regulatory Submission Specialist, or Drug Safety Coordinator.
5. Strengthen inspection readiness by maintaining accurate reporting logs and documentation.

1. Drug Safety Case Processor
2. Pharmacovigilance Reporting Specialist
3. Regulatory Submission Coordinator
4. Clinical Safety Associate
5. Compliance & Audit Readiness Officer

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.