Virtual Dissolution / Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers

Place
Online training
Site visit
Dates
Next Dates
In-house Available
Who should attend?

Dissolution testing specialists, BA/BE managers, Pharmacokineticists, IVIVC scientists, Regulatory affairs managers, R&D scientists, QC and QA managers

Summary

A unique online training course that integrates the in-vitro dissolution testing, equipment requirements, quality control aspects and using dissolution to obtain biowaivers.

Learning Objectives

Understand

  • The role of dissolution studies and dissolution equipment
  • Connecting the dissolution data to pharmacokinetics
  • Quality control aspects of dissolution testing

Learn

  • How to develop dissolution tests and how to interpret them
  • About the requirements for studies in fasting and fed state
  • How to obtain biowaivers with the use of dissolution studies

Key Topics

  • Why do we need Dissolution?
  • Development of dissolution tests
  • Dissolution test equipment and its constraints
  • QC aspects of dissolution testing
  • Dissolution testing in stability testing
  • Use of dissolution studies to obtain biowaivers

Trainers

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Tour info

Price per Delegate (EUR)

Online Training

1350.00

Public Training

Register Now

Testimonials

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Contact us

Doris Waruru

d.waruru@symmetric.events
+420 277 278 697