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

All Pharmaceutical products come in contact with external components right from the manufacturing process till the actual consumption. During this process small amounts of chemicals may be extracted/ leached upon contact with other material which poses a health risk to the patient. E&L studies therefore play an important role in verifying the safety of a drug product over its lifetime. Recently USFDA is increasingly taking interest in the interactions of pharma packaging material, containers and delivery devices with drug product or patient.

CPhI Conferences is organizing the Pharma Extractables and Leachables Forum taking place from 6 - 7 February 2020 in Hyderabad. This is a perfect platform for professional to build a strong foundation for successful E&L Studies. The E&L forum will bring together many different skill sets from a number of different disciplines.


To Register as a Delegate

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

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

Programme Focus

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

Regulatory 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

Assessment , Validation, Analysis: E&L Study Strategies

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 for effective E&L testing

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

Packaging Development and Its Importance

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

Advisory Board Members

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Full speaker list

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Full speaker list • Full conference agenda

Speakers

Christopher Houston

Senior Manager
Quality Technical Support at Bausch + Lomb (PQRI Working Group Representation)

Jason Creasey

Managing Director
Maven E&L Ltd

Dr. Srinivasarao Vaddadi

Principal Scientist & HOD
Lupin Centre for Extractable and Leachable Department

Dr Vandana Singh

Head Analytical Research & Development
Sandoz Development Center, Novartis

Dr.Venkat Manohar

Director
Indian Institute of Chromatography & Mass Spectrometry (IICMS)

Dr. K. S. V. Srinivas

Sr. General Manager – Baxter Global Research Centre
Syngene International

Karthik Ramani, Ph.D.

General Manager, Process and Product Development
Biocon Research Center, Biocon Biologics India Limited

Dr. K.S. Jaganathan

Dy. Director – Production Department
Serum Institute of India

Prasad Ghansham Satam

Associate VP - Packaging Research Development
Aurobindo Pharma

Dr. Md Yakub Iqbal

Senior Manager
Analytical, Syngene International Limited (Baxter Global Research Center)

Parag Nagarkar

Additional Director Head – Regulatory Affairs
Serum Institute of India Pvt.Ltd

Ron Brown

Toxicologist
Risk Science Consortium

Barun Dey

Director, Packaging Development
Dr Reddy’s Laboratories

Sagar Shah

Director Sales & Marketing
Equitron Medica Private Limited

Knowledge Partner

Associate Partner

Exhibit Partner


Media Partners