CT: Drug Safety: Surveillance and Reporting

Common issues and concerns associated with drug safety surveillance within clinical trials are the focus of this course. Topics include the defining and identifying of adverse experiences, verifying drug safety, regulations regarding surveillance of investigational and marketed products, safety reporting requirements, analyzing study results to determine safety, and required actions in the event of safety issues. Useful from both site and sponsor perspectives.

Other Credits: BRN: 16 CE hours.

Note: Elective for Professional Certificate in Clinical Trials Design and Management.

Course Number: FPM-40206
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management

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9/30/2023 - 10/7/2023

$525

Live Online

Cancelled

• SECTION ID:

  174918

• CLASS TYPE:

  Synchronous web-based class meetings that are scheduled to meet online at published times (time/date).

• INSTRUCTOR:
  

  Chiplin, Anne

  Anne Chiplin is an accomplished pharmaceutical professional with 15 years of biopharmaceutical/CRO industry experience in addition to 14 years of pharmacy management experience. She possesses a strong scientific and medical knowledge base and has an excellent understanding of good pharmacovigilance practices and current worldwide drug-safety reporting regulations. Anne gained her pharmacy degree at Nottingham University in England, and has worked in retail pharmacy, Sponsor company and CRO settings. Anne has a thorough working knowledge of clinical trial design, the IND/NDA process and GCP/ICH guidelines. She is currently Director of Safety Evaluation and Risk Management at Intercept Pharmaceuticals in San Diego. She has experience in clinical trial and post-marketing safety report ...Read More

• TEXTBOOKS:

  No textbook required.

• POLICIES:

  No refunds after: 9/30/2023.
  

• NOTE:

  Course will be offered via live remote Zoom delivery fo rmat. Zoom class sessions will be held on two consecutive Saturdays, 9: 00 AM to 3:00 PM (PST), September 30 and October 07.

DATE	DAY	START	END	LOCATION
9/30/2023	Sat	9:00 a.m.	3:00 p.m.
10/7/2023	Sat	9:00 a.m.	3:00 p.m.