Pharmacovigilance Physician Academy
Continuing Professional Development (CPD) for Pharmacovigilance Physicians
Certificate in Essentials of Pharmacovigilance Medical Review: open to individual physicians including those not currently working in Medical Review
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Certificate of Added Qualifications (CAQ) in Pharmacovigilance Medical Review: limited to company sponsorship; intended to impact company practices
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Fellows of ASPVP Program: in development; currently closed to applicants
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Certificate in Essentials of Pharmacovigilance Medical Review
open to individual physicians including those not currently working in Medical Review as well as to "new hires"
Part One: Essential Principles
Accreditation Statement from American College of Preventive Medicine
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American College of Preventive Medicine (ACPM) and the American Society of Pharmacovigilance Physicians (ASPVP) . The ACPM is accredited by the ACCME to provide continuing medical education for physicians.
Pre-recorded video lectures:
1 Causality
2 PV Concepts: seriousness, severity, expected reaction, anticipated event
3 Immunological reactions to drugs
4 Drug induced liver injury (DILI)
5 Company Comment writing style
6 Drug safety and pharmacovigilance regulations
7 Introduction to MedDRA coding
8 Overview of Argus for Medical Review
Written quiz: MedDRA coding using MedDRA Web-based Browser
Please complete at least one module per week.
"New hires" can complete Part 1 within two days.
ACPM designates this enduring material for a maximum of eight AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ACPM is not accredited to offer credit to non-physicians. To determine if activities designated for AMA PRA Category 1 Credit are acceptable for your licensing or certification needs, please contact your credentialing body directly.
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Cost of Part One is $200 (US Dollars)
Click below to Register, then click "Sign Up" in upper right corner of the new window.
Then, click on "Course Catalog" in upper right to register for "Part One"
Part Two: Oracle Argus Safety Database
Complete Medical Review of 24 mock cases using a popular software system. Mock case types include spontaneous, Clinical Trial, and literature. There are four training modules which all must be completed within one month to avoid an additional fee. After completion of Part One, please pay the fee for Oracle Argus database access directly to our partner, ClinSkill. Also, login to your previously used TalentLMS Learning Management System account for additional training material: https://americanpv.talentlms.com/index
Estimated time for completion: 14 hours
Monthly live Q&A (optional)
Cost of Part Two is $399 (US dollars)
Please be sure to enter in the Order notes “American Society of Pharmacovigilance Physicians” so you will be assigned the 24 cases.
Part Three: Certification Fee
Please also email info@AmericanPV.org with name as it should appear on the certificate and your mailing address.
Cost of Part Three is $99 (US dollars)
The Certificate in Essentials of Pharmacovigilance Medical Review does not grant CPD credits.
All three Parts are required to earn the Certificate.
Certificate of Added Qualifications in
Pharmacovigilance
Medical Review
Requirements:
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Open to physicians working in the Pharmaceutical Industry with a job that includes performing Medical Review of Individual Case Safety Reports (ICSRs). Currently your company must sponsor the program, which is intended to impact all Medical Review at the company.
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The CAQ is intended to demonstrate that a candidate has completed a formal education program covering advanced topics in pharmacovigilance medical review, as well as having submitted cases for formal review.
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Training supervised by a physician either at your company or by a consultant familiar with program standards.
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Certificate not valid for AMA PRA Category 1 Credit™ or AOA Category 1 credit.
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Information from the American Medical Association regarding Category 2 credit
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Certificate valid for 10 years. To renew for another 10 years, complete Maintenance of Certification (MOC) activities.
Head of Medical Review: Ask us how to become trained to offer this Certification to your team without cost. Small team? Ask us how to hire a consultant to assist you with content delivery.
Support provided by:
Fellows of ASPVP Program
Pharmacovigilance Physicians provide medical guidance for signal detection and aggregate reports, develop Reference Safety Information, and have knowledge of medical review. Pharmacovigilance is based on epidemiology, the basic science of public health. Fellows have contributed to pharmacovigilance and to ASPVP.
Not currently accepting applicants
See above: Certificate in Essentials of Pharmacovigilance Medical Review
MedDRA Coding
Recommended face to face training offered by MedDRA* is listed at https://www.meddra.org/training/schedule
Coding with MedDRA (1 day, face-to-face)
MedDRA: Safety Data Analysis and SMQs (1 day, face-to-face)
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*not affiliated with American Society of Pharmacovigilance Physicians