Pharmacovigilance Oversight and Inspection Readiness has ended

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Thursday, January 12

8:30am EST

Virtual Welcome and Opening Remarks
avatar for Jonathan


Senior Director of Content & Experience, Momentum Events

Thursday January 12, 2023 8:30am - 8:45am EST

8:45am EST

Recognize the Value of PV Systems to Streamline Communication and Achieve Inspection Readiness 
  • Technology implementation helping the data collection from AER and reduce the burden of HCPs, partners and patients
  • Analyze the different system options like quality, safety and vigilance systems that can be applied to your PV and drug safety 
  • Innovate, adapt and unify processes and information for every stakeholder involved in PV

avatar for Sameer Thapar

Sameer Thapar

Professor Drug Safety Graduate Program, TEMPLE UNIVERSITY
Dr. Sameer Thapar is based in Miami and is the Global Head & Strategic Advisor, MultiVigilanceOperations, in Oracle Health Sciences Center of Excellence and concurrently, Adjunct Professor, TempleSchool of Pharmacy, Masters in Drug Safety. Dr. Thapar has extensive years of experience... Read More →

Thursday January 12, 2023 8:45am - 9:15am EST

9:15am EST

Ensure Streamline Communication Between Partners, CROs and Sponsors
  • Communication is key! Make sure everyone is on the same page and has updated information
  • Call Centers, outsourced partners, off-site teams, vendors and everyone involved need to be on the same page and need to have a clear understanding of their roles and responsibilities when facing an inspection
  • Notify proactively when an inspection or an audit is taking place to provide time and opportunity to have all the information required available

avatar for Garry Flounders

Garry Flounders

Senior Process Lead - Biosimilars, BIOGEN
I have been in drug safety for over 20 years working in multiple senior roles and as an EU QPPV in CROs and consultancies. I started my career with Novartis in the UK and I have now recently taken the plunge and moved to the Netherlands after joining Biogen Biosimilars

Thursday January 12, 2023 9:15am - 9:45am EST

9:45am EST

Thursday January 12, 2023 9:45am - 10:15am EST

10:15am EST

Discuss Strategies and Best Practices for PV Inspection Preparation and How Preparation Efforts Change Depending on the Inspecting Agency 
  • Evaluate different approaches for safety inspection preparation 
  • Discuss the known areas of focus amongst the varying regulatory agencies
  • Streamline cross-functional collaboration and communication to ensure everyone is on the same page. Evaluate best practices for leveraging learnings and findings from previous inspection experiences

avatar for Helena van den Dungen

Helena van den Dungen

Executive Director PV Quality Assurance, ASTELLAS
My professional career (to date) is broadly divided in 3, more or less equal, parts.I started out in pre-clinical and biochemical research, focusing on (neuro-)endocrinology. I obtained a PhD from the Medical Faculty, Vrije Universiteit van Amsterdam, titled: ‘LHRH and Gonadotropins... Read More →
avatar for Kal Elhoregy

Kal Elhoregy

Director, REMS Programs |Drug Safety and Pharmacovigilance, AMNEAL PHARMACEUTICALS
Kal Elhoregy is an accomplished healthcare industry executive  with 24+ years’ experience focused on implementation of Risk  Minimization Programs, Quality Management Systems (QMS)  and Pharmacovigilance (PV) Compliance within the  pharmaceutical industry. In his current role... Read More →
avatar for Jaylaxmi Nalawade

Jaylaxmi Nalawade

Associate Director - Pharmacovigilance and REMS, LUPIN PHARMACEUTICALS
avatar for Randy Levitt

Randy Levitt

Director, Pharmacovigilance and Medical Affairs, PALADIN LABS

Thursday January 12, 2023 10:15am - 11:00am EST

11:00am EST

The Importance of Pharmacovigilance to Keep Patient Safety
  • Explain how patient Safety and Pharmacovigilance need to work together.
  • What is the importance to keep the patient safe before and after post-marketing activities?
  • Why is important to strengthen Pharmacovigilance outside of Pharma company ( Pharmacovigilance in hospitals, pharmacies and etc).

avatar for Janaina Brothers

Janaina Brothers

Manager, Aggregate Report Analyst, PFIZER
Janaina (or Jana) graduated from the University of Sao Paulo in 2014 as a pharmacist and biochemist, and she is currently pursuing a Master of Science in Regulatory Affairs at San Diego State University. She is extremely passionate about pharmacovigilance activities, in which she... Read More →

Thursday January 12, 2023 11:00am - 11:30am EST

11:30am EST

Leverage Learnings and Challenges from PV Audits to Promote and Ensure Inspection Readiness
  • Examine the different types of pharmacovigilance audits that can be executed at various levels/components of the pharmacovigilance system
  • Embrace the audit as an “inspection exercise” and a critical piece of your inspection preparation
  • Maximize the different audits to gather useful insights that will help reduce the inspection risk

avatar for Josue Bautista Arteaga

Josue Bautista Arteaga

GCP/PV Auditor and Founder of #PharmacovigilanceEnEspañol, NOVARTIS
Founder and Member of #PharmacovigilanceEnEspañolIndustrial Pharmaceutical Chemist with 16 years of experience in the pharmaceutical industry.Collaborator of DIA newsletter. Advisor to the Pharmacovigilance Institute. Chairman and ambassador for LATAM of the Global Pharmacovigilance... Read More →

Thursday January 12, 2023 11:30am - 12:00pm EST

12:00pm EST

Thursday January 12, 2023 12:00pm - 1:00pm EST

1:00pm EST

PV Requirements in Brazil following ICH Guidelines Implementation

  • Recognize PV requirements in Brazil
  • Describe the path to implement ICH guidelines and the challenges for pharma companies.
  • Illustrate challenges and opportunities

avatar for Raphael Pareschi

Raphael Pareschi

Patient Safety Lead/ Head of Pharmacovigilance Brazil, ROCHE
Raphael has more than 14 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also... Read More →

Thursday January 12, 2023 1:00pm - 1:30pm EST

1:30pm EST

Learn the Current State of PV Affairs in Argentina

  • Applicable Pharmacovigilance Legislation in Argentina
  • Recent changes and challenges
  • LHA Interaction with the Pharmaceutical Industry

avatar for Carla Massironi

Carla Massironi

Country Safety Head Argentina, Global Pharmacovigilance, SANOFI
“Pharmacist graduated from the University of Buenos Aires with a degree in Hospital Management and Administration and Radiopharmacy, Diploma in Patient Safety and Public Health Administration (Austral University), as well as a specialization in Market Access and Marketing, with... Read More →

Thursday January 12, 2023 1:30pm - 2:00pm EST

2:00pm EST

New-Age Benefit Risk Assessment for Drugs
Be sure to have continuous exercise throughout the product life cycle to evaluate the favorable and unfavorable effects of the drug.

  • Weigh the benefit and risks of different forums and initiatives
  • Discuss the appropriate usage of metrics
  • Consider involving patients to factor in their perspectives on the benefits and risks of the product

avatar for Siva Kumar

Siva Kumar

Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit, TEVA

Thursday January 12, 2023 2:00pm - 2:30pm EST

2:30pm EST

Thursday January 12, 2023 2:30pm - 2:45pm EST

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