Industry Landscape

Extractables and Leachables (E&L) has become crucial aspect in the pharmaceutical industry due to stringent regulatory guidelines for increased patient safety. The pharma E&L testing market is expected to expand at a compound annual growth rate of 12.1% from 2015 to 2020. This growth is driven by the increasing adoption of single-use technologies and rigorous inspections by regulatory agencies. CRO'S are also evolving as development partners thereby further expanding the need for E&L studies. Emerging markets such as India and China are becoming hubs for contract manufacturing for such services, as these countries are building strong local expertise in analytical laboratory testing.

About Pharma Extractables & Leachables Forum

Examining extractables and leachables is an important safety issue as these substances can adversely impact the health of patients. In the recent years regulatory bodies have been increasingly focusing on the migration of mobile chemical substances from plastic components used in the packaging and manufacturing processes of pharmaceutical products.



The Pharma Extractables and Leachables Forum organized by CPhI Conferences will enable the audiences to Identify, analyze and assess them during R&D formulation stage, manufacturing process and ensuring right packaging. Leading Global E&L Experts and Toxicologist will share insights on the guidelines and recent updates on analytical and validation method testing innovations, and the impact of E&L. This is a perfect platform for professional to build a strong foundation for successful E&L Studies.

To Register as a Delegate

Sailee Patne
+91 22 6172 7311
+91 88280 65252
sailee.patne@informa.com

Extractables and leachables studies are crucial for the protection of patients, the success of drug products, and the adherence to regulatory expectations.


Key Benefits of Attending this Forum

  • 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 group exercises, case studies and interactive sessions

Who Should Attend?

  • Analytical Research
  • R&D
  • Extractable and Leachable/ E&L
  • Formulation
  • QA/QC
  • Regulatory Affairs
  • Packaging Development

Who Should Partner

  • Analytical Testing Services
  • Batch Release & Stability Lot Testing
  • Medical Devices
  • Stability Studies
  • Chemical Characterization
  • Analytical Method Development
  • Packaging

Programme Focus

This 2-day programme will focus on impact of regulatory amendments on E&L Studies and evaluate

Regulatory, Validation and Quality Assessments Overview

Updates on latest global regulatory guidelines for effective risk analysis and quality assessment of drug product in E&L testing...read more

Toxicological Risk Assessments in Biopharmaceutical Drug Products

Understand analytical research methodologies with latest tools and techniques for effective E&L testing along with importance of risk assessment and safety analysis for better consumer health... read more

Data Integrity: A Vital Factor to Qualify the Regulatory Audits

Building data sets and libraries for better identification of Extractable and Leachable... read more

Packaging Development and Its Importance in E&L Studies

Identifying right vendor for suitable packaging development that reduces risk aspects related to E&L studies... read more

Speakers

Dr. Andrew Feilden

European E&L Strategic Director
Hall Analytical

Dr. Atish Sen

Staff Scientist, Analytical Sciences - Inhalation Product Development
AstraZeneca

Dr. Carsten B. Senholt

Partner & CTO
SAXOCON

Chander Mani

Application Engineer
Agilent Technologies

Dr. Clemens Guenther

Director Senior Expert Nonclinical Safety
Bayer AG

Dr. Daniel Norwood

Principal Consultant
Feinberg Norwood & Associates Pharma Consulting

Dr. Desmond Hunt

Principal Scientific Liaison
United States Pharmacopeia (USP)

Dominic Roberts

Product Marketing Manager GC Orbitrap
Thermo Fisher Scientific

Douglas J Ball

Managing Partner &Toxicologist
D&B ChemTox, LLC

Dr. Greg Erexson

Senior Principal Research Scientist
AbbVie, Inc

Jason Creasey

Managing Director
Maven E&L Ltd.

Kate Comstock

Senior Pharmaceutical Products Manager, Pharma and Biopharma Marketing - Chromatography & Mass Spectrometry Division
Thermo Fisher Scientific

Dr. Lee Nagao

Senior Director, Science, Regulation & Policy
Faegre Drinker (Member of ELSIE)

Dr. Roger Pearson

President Analytical Services
Aspen Research Corporation

Dr. Ron Brown

Toxicologist
Risk Science Consortium and Former FDA

Sudhakar Nagaraj

Principal Scientist, SLS
Global Regulatory and Validation Consulting group, Pall Biotech

Dr. William Beierschmitt

Managing Partner & Toxicology Expert
D&B ChemTox, LLC

Testimonials


 

Gold Partners

Thermo Fisher Scientific Tagline Pall Biotech linear

Silver Partner



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