Bioequivalence & Dissolution Testing

Place
Renaissance Wien Hotel, Vienna, Austria
Site visit
Dates
Next Dates
In-house Available
15 - 17 March 2021
Who should attend?

BA/BE managers, Pharmacokineticists, Dissolution testing specialists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers, Bussines develepment managers, R&D scientists & managers, Principle scientists

Summary

This unique 3-day training course integrates the in-vitro dissolution testing, pharmacokinetics and biostudies as related to solid dosage formulations.

Learning Objectives

  • How to design a bioequivalence study?
  • The statistical design needed to get regulatory approval
  • The role of dissolution studies in screening formulations
  • Connecting the dissolution data to pharmacokinetics
  • The predictive power of pilot studies
  • The requirements for studies in fasting and fed state
  • How to develop dissolution tests and how to interpret them?
  • The use of dissolution studies to obtain biowaivers
  • Drug absorption and its effect on dissolution and pharmacokinetics
  • The relationship between formulation and bioavailability

Key Topics

  • Development of dissolution tests and their biomimetic value
  • Prediction of drug substance pharmacokinetics
  • Consideration of pKa and sites of adsorption
  • Design of a biomimetic dissolution test
  • Value of IVIV correlations - regulatory viewpoint
  • Biostudy results vs. statistical requirements
  • Relationship between formulation and bioavailability
  • Use of dissolution studies to obtain biowaivers

Programme

  • All training materials will be provided in printed and digital form
  • All delegates will receive printed and LinkedIn certificates
  • Real life case studies
  • Five hours of networking with industry peers

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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.

Ing. Helmut Schütz

CEO

BEBAC

Ing. Helmut Schütz studied Chemical Engineering in Vienna and he is an independent consultant in the domain of bioavailability and bioequivalence studies. Mr. Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department. In 2004 he founded the consultancy company BEBAC. He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 36 years and 600+ BA/BE studies. Helmut Schütz is a member of the International Pharmaceutical Federation, the European Federation for Pharmaceutical Sciences, the American Association of Pharmaceutical Scientists, the International Biometric Society, the Austrian Pharmaceutical Association, and the Austrian Association of Consulting Engineers.

Ing. Helmut Schütz

CEO

BEBAC

Ing. Helmut Schütz studied Chemical Engineering in Vienna and he is an independent consultant in the domain of bioavailability and bioequivalence studies. Mr. Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department. In 2004 he founded the consultancy company BEBAC. He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 36 years and 600+ BA/BE studies. Helmut Schütz is a member of the International Pharmaceutical Federation, the European Federation for Pharmaceutical Sciences, the American Association of Pharmaceutical Scientists, the International Biometric Society, the Austrian Pharmaceutical Association, and the Austrian Association of Consulting Engineers.

Tour info

Price per Delegate (EUR)

Online Training

1500.00

Public Training

2295.00
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Testimonials

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Contact us

Doris Waruru

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