This seminar will discuss the new requirements, differences from the older requirements, and tips to not only be compliant but processes to document how you address safety events in your clinical trials. Topics covered include

- What has changed from earlier?
- How do these changes impact ongoing and recently completed clinical trials?
- Best practices to implement new safety reporting processes
- Do's and Don'ts of safety reporting

Areas Covered in the Seminar:

- Current regulatory requirements.
- Rationale for these changes.
- Role of clinical investigators and sponsors.
- Amending existing SOPs and/or creating new ones.
- Training requirements for personnel.
- Good documentation practices for safety monitoring.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

- QA/QC/Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Pharmacovigilance professionals
- Clinical trial specialists
- Project Managers