Qepler | summits & conferences | 2nd Annual Extractables & Leachables Summit, 22-23 October 2020
Event Location:
Prague, Czech Republic
Venue:
Novotel Praha Wenceslas Square Hotel Katerinska 1476/38
Date:
22 October 2020 - 23 October 2020
Language:
English

Early Bird discounts:
Register early to save € 500 for the Individual ticket, € 600 per person for 2-3 Delegates, € 700 per person for 4+ delegates from the same company until 15 May 2020.

Conference Overview

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

The featured talks on:

  • Regulations and E&L: Regulatory Updates and Adoption, EMA, FDA, PQRI, ICH Guidelines, USP
  • Best Practices for E&L testing
  • Excelling E&L Strategy: Strategy Development, Analytical Method Selection and Validation, Chemical Profiles. Risk-Based Evaluation.
  • Building Effective E&L Study: Mapping Activities for the Development Phase, Techniques for the QC, Information Identification and Effective Use, Extraction and Right Conditions Selection, Leachable Study Monitoring and Compounds Selection, Leachable Study Design.
  • E&L Study Design: Main Changes, Action Plan, Step Wise Implementation.
  • Boosting E&L Assessment: Successful Strategy Implementation, E&L Study Design, Method Selection.
  • Successful Toxicological Risk Assessment Principles, Concepts and Tools. Substances Requirements, Effective Data Search, Safety & PDE. Substances with Poor Toxicological Information.
  • Quality Control, LCM, Change Management and E&L Testing: Qualification of Extractables & Leachables.
  • Extractables Data: Interpretation, Use, Exposure Identification, CCS, SUS.
  • Manufacturing Excellence: E&L minimisation, Risk-Based Evaluation, Testing Strategies, Single Use Equipment Selection.
  • Single-Use Systems: Risks Classification, Regulations Implementation in Study Design.
  • Packaging and E & L: Packaging Materials, USP Standards, Chemical Characterization, Quality Control, Process Development, Materials Selection.
  • Plastics and E & L: Classification, Types, Construction, Related Additives. Chemical and Physical Characteristics.
  • CCS & Materials: Practical Examples of Use of Different Types of Polymers. Polymers Composition.
  • Elastomers and E & L: E&L Assessment, Composition, Minimization Strategy.
  • Glass and E & L: Composition, Extractables Types, Risks Management and Evaluation, Extractables minimization. Glass Use in Parenterals and Associated Challenges.
  • Bioproduction and E & L: Related Issues, Manufacturing Process, Influence on the Stability, Storage, Administration.
  • Bioproduction view on the E & L evaluation: practical examples.
  • Combination Products and E&L: Regulations, Challenges Overcome, Risks assessment.
  • Lyophilized Products and E&L: Primary Packaging, Leachable Studies Design and Evaluation. Regulations Impact on Combinations Products in Administration Procedures: 21CFR Part 4.

Meet our Speakers

SNAPSHOT OF EVENT

OUR ATTENDEES

AbbVie - AiCuris Anti-infective Cures GmbH - Angelini ACRAF s.p.a. - B. Braun - Bayer - Bayer AG - Borealis Polymere GmbH - Brooks Life Sciences - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Pharma Packaging International NV - Datwyler Sealing Solutions - EirGen Pharma - Engelhard Arzneimittel GmbH & Co KG - F. Hoffmann-La Roche Ltd - GSK - GSK Vaccines - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Intertek (Schweiz) AG - Iterum Therapeutics - Lyomark Pharma GmbH - Maven E&L Ltd - Medichem - Merck - Merck KGaA - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk - Pall Biotech - Patheon, by Thermo Fisher Scientific - PHARMIDEA SIA - Purus Plastics - RMS Foundation - Safetree Consulting e.U. - Sandoz - Sanofi - Sanquin Plasma Products - Sartorius Stedim Biotech - SAS Laboratoire Aguettant - SCHOTT AG - SE Tylose GmbH & Co. KG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - Synthon Biopharmaceuticals BV - Vifor (International) AG - West Pharmaceutical Services GmbH & Co. KG - ZETA GmbH - Others