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A Practical Approach to Design and Implementation (com) A

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PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation


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The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities..

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing of this course, participants should be able to:

  • Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:

  • Develop a high-level PV audit strategy

  • Identify the PV activities and processes subject to PV audit

  • Develop risk assessment criteria

  • Identify the PV audit universe – entities subject to PV audit

  • Categorize the entities subject to PV audit

  • Perform risk assessments

  • Prioritize entities for audit according to relative risk

  • Prepare a 3-5 year PV audit plan

  • Identify procedures/tools to monitor PV quality of third parties

Who will Benefit:

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

  • PV Quality Assurance StaffPV Compliance professionals

  • Quality auditors

  • Pharmacovigilance Auditors

  • Relevant Pharmacovigilance Staff

  • PV Service Provider Relationship Managers

  • MAH Affiliates responsible for Pharmacovigilance


AGENDA

Day 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Review of FDA and EMEA requirements for risk based PV audits
The pharmacovigilance system and the quality system
Strategic level audit planning
Hands on exercise
PV activities and processes subject to PV audit
Risk assessment criteria
The PV audit universe - all entities subject to PV audit
Safety data exchange agreements (SDEAs) and vendor contracts

Day 02(8:30 AM - 4:30 PM)

Stability (shelf-life) studies
Categorization of the entities (PV Audit Universe)
Risk assessments
Prioritization of entities for audit according to relative risk
3-5 year PV audit plan
Hands on exercise
Procedural documents, e.g. SOPs
Identify procedures/tools to monitor PV quality for oversight of third parties
Q & A


SPEAKER

Behnam Davani

Subodh Bhardwaj
Consultant

Dr Subodh Bhardwaj is a Physician and Clinical Pharmacologist with 30 years of experience leading research, development and pharmaco-vigilance across varied therapeutic areas with Sanofi group, Serum Institute of India, Arable Corporation USA & Surgipharm Uganda. He is MBBS from Medical College Jammu India (1981) and following 7 years in Internal Medicine, he was awarded- MD Pharmacology from the prestigious AMU, India (1990). His initial work included pioneer studies of epidemiological profile of adverse drug reactions in India in 1988 with the ICMR, where he also researched trace elements, hypertension and Diabetes mellitus. He joined the industry in 1993 and then diversified across pharmacovigilance of r-DNA infertility drugs, Growth hormone/ Somatostatin Viral and Bacterial vaccines, Mabs for Rabies & ONCO-BCG for superficial bladder cancer, Meningococcal & pandemic, seasonal influenza vaccines. Leading pharmacovigilance in association with WHO Biologicals he assisted teams to investigate SAEs, SUSARS, and spontaneous AEs globally.

As Director Scientific affairs, Regulatory affairs & Public policy with Sanofi Pasteur he headed the PV operations in India for all licensed products and AEs during clinical trials on INDs, post marketing AEs for all products according to EU/ USFDA regulations reporting to GPVD, Lyon ensuring high standard of compliance & product life cycle management. Well versed with pharmacovigilance principles & practices including Audit- he chaired the Pharmaco-vigilance & clinical trials 4th International conference in London in 2015 -conducting a workshop on Vaccine vigilance. He has planned and conducted more than 50 multicentric, multi-country ICH-GCP Compliant clinical trials including a large sample size post marketing phase IV study (MMR) on 500,000 Egyptian children. He has 60 publications in peer reviewed National and International journals and recently authored a chapter in Pharmaceutical Medicine & Translational Clinical Research published by Elsevier in 2018. He is Member BRAPP, ESOP, Phd guide, and currently works as an Independent Global Biopharmaceutical consultant in New York with acclaimed agencies sharing his knowledge on topics of clinical research and pharmaco-vigilance.


Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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