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THE PHARMACOVIGILANCE AUDIT: HOW TO PREPARE FOR AN INSPECTION


SEPTEMBER 07, 2023,

TIME 12:30 PM - 03:30 PM EDT (US) | 05:30PM - 08:30 PM (UK)


HALF DAY INSTRUCTOR LED VIRTUAL COURSE.


3 RAC CREDITS


Purchase Options


CHOOSE A PURCHASE OPTION




$1,184.05


EARLY BIRD ONE DIAL-IN ONE ATTENDEE - LIVE



or pay in installments:

Less

You get one log-in for the live 3 Hrs Virtual Seminar for one participant,
presentation materials, Certification and the opportunity to ask questions by
phone and email.

$4,163.81


LIVE GROUP UP TO 5 PARTICIPANTS



or pay in installments:

More

You get upto 5 log-in for the live 3 Hrs virtual seminar for all the
participant, presentation materials and the opportunity to ask questions by
phone and email

$1,544.62


RECORDED ACCESS SINGLE USER



or pay in installments:

More

You'll have single user access to log-in for an archived recording of the entire
3 Hrs virtual seminar, including the Q&A period . You can log in any time of day
or night. You'll also receive all presentation materials, plus an audio
recording and transcript for the entire session. Delivery is approximately 48
hours after the session

$4,638.62


RECORDED GROUP UP TO 5 PARTICIPANTS



or pay in installments:

More

You get 5 log-in for the live 3 Hrs virtual seminar for all the participant,
presentation materials and the opportunity to ask questions by phone and email

Register Now


PREPARING FOR A PHARMACOVIGILANCE INSPECTION

This training course will give you a jump-start on how to prevent common
problems that are found during regulatory inspections for drug safety and
pharmacovigilance. It will include examples based on the top ten findings by US
and EU pharmacovigilance inspectors. You will be able to use this information
straight away to make the changes you need to address these common failings and
avoid the findings.

You can be sure regulatory authorities will inspect your drug safety operations
- and there is no excuse for poor preparation.

This training course is designed to give pharmaceutical firms operating in the
US and EU practical information, best practices and insight to help ensure
compliance with the most recent drug safety and pharmacovigilance regulations.

Whether you're planning an internal audit of your processes, anticipating an
audit from a business partner, or preparing for your FDA or EMA inspection, this
course will give both old hands and new staff the insights needed to be ready
for regulatory scrutiny of your drug safety and pharmacovigilance specialists,
safety processes, safety systems and reporting.


WHAT YOU’LL LEARN

 * The top ten findings from US and EU pharmacovigilance inspections
 * Why the pharmacovigilance audit is important to ensure Good Pharmacovigilance
   Practice
 * The impact of global regulations on international safety reporting and review
   methods
 * The objectives and components of a pharmacovigilance audit
 * Practical steps to help you begin and implement your audit
 * The requirements of all applicable regulatory bodies for your products
 * Initiating company practices for drug safety across the product lifecycle
 * Examples of what NOT to do


COURSE AGENDA

The Pharmacovigilance Audit

 * Audits vs. Inspections
 * Types of audits & inspections
 * Who can be audited?
 * Overview of the pharmacovigilance audit
 * Typical pharmacovigilance current process model
 * Best practice approach to enhancing process model
 * Achieving best practices through the pharmacovigilance assessment
 * Value derived
 * Audit scope
 * Company sources of information to be examined
 * PV checklist
 * PV risk profile
 * Audit report table of contents
 * Prioritization of findings
 * Do’s and don’ts during an inspection
 * Top 10 inspection findings
 * Preparing for an inspection
 * Quiz Time


WHO WILL BENEFIT

 * Clinical safety staff
 * Pharmacovigilance specialists
 * Regulatory affairs professionals
 * Quality management specialists
 * Management involved in clinical oversight.
   

FACULTY STEVE JOLLEY 

DRUG SAFETY AND PHARMACOVIGILANCE CONSULTING: AUDITING, SIGNALING, TRAINING

MENDHAM, NEW JERSEY, UNITED STATES

Steve Jolley is a subject matter expert in all areas of global safety compliance
and signal detection.

Steve has 37 years’ experience in drug safety & pharmacovigilance and has worked
with 300 clients in North America, Europe, Japan, India, China, the Middle East,
and Africa. He holds degrees in mathematics and computer science from Cambridge
University, England. He is an Adjunct Professor at Rutgers University and
developed part of their Master's degree in Drug Safety and Pharmacovigilance.

Steve is a featured speaker with FDA, EMA and MHRA at conferences and webinars
on auditing, signaling and data mining. He is a member of DIA’s training faculty
and is an instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate
Program. In 2010 Steve was elected as chairman of the DIA’s Clinical Safety and
Pharmacovigilance steering committee for North America. 


3.0 RAC CREDITS


RAPS - This course has been pre-approved by RAPS as eligible for up to 3.0
credits towards a participant's RAC recertification upon full completion.


World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society
(RAPS) RA Professional Development Portal provider. World Compliance Seminars is
committed to enhancing the ongoing professional development of regulatory
affairs professionals and other stakeholders through appropriate regulatory
affairs learning activities and programs. World Compliance Seminars has agreed
to follow RAPS-established operational and educational criteria




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