Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development

Place
Your Company Premises
Site visit
Dates
Next Dates
In-house Available
Who should attend?

Heads of R&D, Formulation Development Scientists, Formulation Technician, Analytical Scientists, R&D Analytical Chemists, R&D Associates, Principal Scientists - Pre-Formulation, Senior Research Scientists

Summary

This 2.5-day in-house training course focuses on particular challenges of generic solid immediate release dosage forms development. It will help formulators to learn the ways of minimizing their experiments in a way to remove the analytical burden from the R&D analytical.

Learning Objectives

Learning & Key Takeaways

  • Establishing an effective and cooperative relationship between the formulation development department and analytical research
  • The value of pre-formulation work – formulation development starts in the analytical laboratory
  • The importance of technology transfer which may become a rate limiting step in the completion of a project

Key Topics

  • Establishing an effective generic drug development program
  • The importance of API in the development of solid oral dosage forms
  • Excipients as important as the API for the formulator
  • Where do we start? - The pre-formulation laboratory
  • Fitting the pieces together for instant release solid oral dosage forms
  • De-risking your product - The challenge of QbD
  • The formulation report – Common errors regarding establishment of specifications

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

Public Training

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543