Take advantage of our $1507.50 price by registering early!* After Friday, June 21, 2019, costs are $1687.50.
The
European Medicines Agency’s (EMA) post-marketing Pharmacovigilance (PV)
regulations known as the EMA PV Modules are designed with the expectation that
companies adhere to this new global “gold” standard regarding the receipt,
processing, managing, maintenance, and submissions of Adverse Event (AE) data
to the relevant health authorities. Not only are these standards applicable to
EU-based companies, but any company marketing products (drugs or devices) on a
global level. We will review the FDA and EMA expectations, and apply them to
the various PV audits.
This course is designed
for those that already have some post-marketing PV experience (either
experienced auditors or practical hands-on PV staff). Learners will receive training
on how to audit PV at the local level, but to do it with a global perspective.
The course will focus on understanding PV agreements, and reporting to health
authorities and the relevant auditing mechanisms, including the generation of
the annual audit plan based on a risk assessment; generating audit agendas once
the plans are put into play; understanding Safety Data Exchange Agreements
(SDEA); understanding Periodic Safety Update Reports (PSURs); requesting
pre-audit information of PV departments in-house, at a license/marketing
partner, vendor, or distributor; and generating the correct categorization of
findings for the audit reports.
- Determine whether Safety Data Exchange Agreements
are adequate
- Determine whether PSURs are covering
the correct information and timeframes
- Prepare annual PV audit plans
- Prepare relevant PV audit agendas
based on the type of PV audit required
- Request relevant PV data as part of
the audit preparation activities
- Conduct PV audits with a focus on
different PV topics
- Prepare audit findings and
categorizations
- Heads of Pharmacovigilance Quality Assurance
Departments
- Pharmacovigilance Auditors
- Heads of Pharmacovigilance
Departments
- Relevant Pharmacovigilance Staff
- PV Safety Scientists
- Quality Assurance Staff responsible
for pharmacovigilance self-inspections
The course will be led by one of the following
instructors:
Sharon
Donatucci
Vaska Tone
Click here for complete trainer
biographies
Day One: 8:30 a.m. – 5:00 p.m.
- EMA & FDA Safety Reporting: When and How?
- Who to Audit: Internal Systems, Affiliates, License Partners, Vendors,
and Distributors
- PV Audit Plans, Scope and Agendas
- Understanding Different Contracts/Agreements
- Hands-on Exercise: Designing an annual audit plan – risk based; Preparing
the correct scope for the various PV audits; Preparing the correct audit
agenda (2, 3, or 4 day audits); Review of various contracts (determine what
is wrong with them)
Day
Two: 8:30 a.m. – 5:00 p.m.
- Auditor Preparation: PV Audit Questionnaires & Checklists
- PV Audit Conduct
- Hands-on Exercise: Use of the pre-audit questionnaire –review of several
examples; Use of PV Audit Checklists; Follow the AE: Review of PV tracker,
source document(s), cases MedWatch/CIOMS), submissions; Role Playing
Registration
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
cancellation policy
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-002-L01-P.
Released: 7/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
