PV (Pharmacovigilance) Audit Strategy Planning – A Practical Approach to Design and Implementation: 2-Day In-Person Seminar

By: Subodh Bhardwaj, Consultant
Location :- DoubleTree by Hilton San Francisco Airport, CA | Thursday, October 25, 2018 | Friday, October 26, 2018

We need the below information to serve you better

Course Description:

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..

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 Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance

Course Outline

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Day One (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • 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 Two (8:30 AM – 4:30 PM)
  • 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

Meet Your Instructor

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.

Venue

Location :
DoubleTree by Hilton San Francisco Airport
835 Airport Blvd,
Burlingame, CA, 94010-9949, USA

October 25-26, 2018


How to Reach

General Driving Directions:

Directions from San Francisco International Airport, CA: 4.8 mi.
  • Depart from San Francisco International Airport, CA
  • Take ramp left for US-101 South toward San Jose (2.5 mi.)
  • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
  • Turn left onto Broadway (0.2 mi.)
  • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
  • Turn left onto Airport Blvd (0.7 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from San Jose International Airport, CA: 31.1 mi.
  • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
  • Bear left toward Skyport Dr (0.3 mi.)
  • Keep straight onto Skyport Dr (0.1 mi.)
  • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
  • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from Metropolitan Oakland International: 27.5 mi.
  • Depart Airport Dr toward Airport Dr (0.3 mi.)
  • Turn right onto Alan Shepard Way (0.0 mi.)
  • Turn right onto John Glenn Dr (0.5 mi.)
  • Turn right onto Ron Cowan Pkwy (0.0 mi.)
  • Take ramp left for Airport Dr (0.7 mi.)
  • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
  • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
  • Take ramp right for I-880 South toward San Jose (6.7 mi.)
  • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
  • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

$1,799

Seminar One Registration

October 25-26, 2018, San Francisco, CA

Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation: 2-Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of San Francisco, CA

Think Escape Party Bus
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport.

Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.


City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino Tour San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity