Trainings By Informa Markets
Informa


Extractables & Leachables Forum

Driving Excellence in E&L Studies

02 Sep - 03 Sep 2020   |   Virtual Course


Course Overview

The studies of Extractables and Leachables (E&L) substances are extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. When making Parenteral Drug Products, pharmaceutical companies need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biopharmaceuticals – have become an additional concern.

To address these issues, we at Informa Markets in India are pleased to announce our premier edition of ‘Extractables & Leachables Forum’ scheduled on 2nd & 3rd September 2020.

Program Focus

Regulatory and Quality Assessments Overview
Assessment, Validation and Analysis of E&L Studies
Importance of Data Integrity in E&L Studies
Packaging Development and Its Importance in E&L Studies

Benefits of Attending


Evaluate the latest regulatory guidelines and global expectations

Gain insights by understanding risk based approach analytical testing method in E&L testing

Understand techniques to asses, validate and analyse E&L studies

Master the best practices in E&L studies with case studies and interactive sessions

Our Speakers

Dr. Anja Cerstiaens

Director E&L Services
Nelson Labs Europe

Dr. Clemens Guenther

Director Senior Expert Nonclinical Safety
Bayer AG

Diane Paskiet

Director – Scientific Affairs
WEST Pharmaceutical Services & Chair of Product Quality Research Institute (PQRI) in Development Technical Committee (DTC)

Dr. Elizabeth Martin

Project Toxicologist
AstraZeneca

Jason Creasey

Managing Director
Maven E&L Ltd.

Ken Wong

Deputy Director
Sanofi Pasteur

Patricia Parris

Global Risk Assessment Services Toxicologist
Pfizer

Ron Brown

Former FDA & Toxicologist
Risk Science Consortium

Steve Zdravkovic

Senior Research Scientist
PPD

Who Should Attend?


The Extractables & Leachables Forum will bring together leading E&L experts and decision makers from different departments of the industry. These delegates will be coming to the forum to get the latest updates on regulations, best practice and compliance advances in the sector and much more.

Industries / Categories:

  • Pharmaceuticals
  • Biopharma
  • Lifesciences

Departments:

  • Manufacturing/Production
  • Analytical Research
  • R&D
  • Extractables & Leachables (E&L)
  • Formulation
  • QA/QC
  • Regulatory Affairs
  • Packaging Development


Who Should Partner?

The Pharma E&L Forum is designed for professionals from Pharmaceutical, CRO industries working in thefollowing domains:

  • Analytical Testing Services
  • Batch Release &Stability Lot Testing
  • Medical Devices
  • Packaging
  • Stability Studies
  • ChemicalCharacterization
  • Analytical MethodDevelopment




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