30 October – 01 November 2019

Bucharest, Romania

From Science to Guidance and Practice

From Science to Guidance and Practice - 5th Edition of the International Conference

This year's conference will discuss dissolution regulatory requirements, comparison between US FDA and EMA dissolution curves, setting correct dissolution specifications, and benefits of automatizations. Other important subjects will focus on characterization of physical and chemical material properties under precise controlled conditions.

Lectures include:

Day 1:

  • Comparison of the regulatory requirements to compare dissolution curves between US FDA and EMA
  • Setting Meaningful Dissolution Specifications
  • How to prove that dissolution reflect in vivo: apparatus, media selection
  • EMA Draft guideline on quality and equivalence of topical products – The role of in vitro methodologies
  • Principles and benefits of Dissolution automation
  • The "legend" of peak purity check in HPLC/DAD
  • Purification with Flash Chormatography & Prep HPLC
  • Understanding laboratory data integrity in thermal analysis
  • 6 points to consider when purchasing a constant climate chamber in the pharmaceutical industry

Day 2:

  • Data Integrity. LabX solution for automated data integrity
  • In vitro release methodologies for rectal suppositories
  • USP on Dissolution related Chapters, Processes and Resources
  • Thermal analysis in the field of pharmaceuticals
  • Investigation of viscoelastic properties of cosmetic and pharmaceutical formulations
  • Q3 similarities. Regulatory requirements and relevance

For more information and to register, please send an email to catalina.urs(at)ofsystems.ro.

Visit Us

  • From Science to Guidance and Practice
  • 30 October – 01 November 2019
  • Bucharest, Romania
  • Ramada Bucharest Parc Hotel