Pharmaceutical Impurity Challenges

Place
Renaissance Wien Hotel, Vienna, Austria
Site visit
Dates
27 – 28 April 2020
Who should attend?

Analytical chemists, Formulators, Regulatory affairs, Quality assurance staff, Purchasing/Supply officers, Business development

Summary

The course will help define the different sorts of impurities that may occur in drug substances, finished dosage forms and excipients. It will help in differentiating between degradation products and other impurities and will look at the requirements for determining degradants using validated analytical methods incorporated into regulated stability testing programs in accordance with ICH/EMA and revised FDA requirements. Course will be also devoted to the issues surrounding the genotoxic impurities guidance ICH M7 and will include aspects related to the determination of the genotoxic potential of compounds. You will look at the analytical challenges involved in detecting compounds such as the N-Nitroso contaminants found in the sartans and other API’s.

Aims

Learning & Key takeaways:

Day 1

  • The course will start with classic issues of impurities in terms of degradation and side reactions of the drug substance as covered by ICHQ. It will deal with ICHQ3 impurities (volatile organics & heavy metals) and look at the control approaches to be followed in order to comply with the current regulations
  • A detailed description of issues and techniques related to packaging which require leaching and extractable determinations will complete day one

Day 2

  • Day two will be devoted entirely to the issues surrounding the genotoxic impurities guidance ICH M7 and will include aspects related to the determination of the genotoxic potential of compounds
  • You will look at the analytical challenges involved in detecting compounds such as the N-Nitroso contaminants found in the sartans and other API’s

Key Topics

  • General Impurity management and control
  • Analytical method requirements for validation/verification
  • Elemental impurities, ICH Q3D Guideline
  • Residual Solvents, ICH Q3C guidance
  • Leachables and extractables: issues and techniques related to packaging
  • Genotoxic Impurities, Interpretation of ICH M7
  • Case study: The Valsartan chaos and the regulatory responses

Programme

  • Pharmaceutical impurities are easy to define, but are very difficult to control
  • You will look at the current regulatory requirements related to this complicated challenge
  • Training materials will be provided in printed and digital form
  • All delegates will receive printed and LinkedIn certificates
  • 5 hours of networking with industry peers
  • Networking cocktail reception
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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.

Tour info

Testimonial

Price per Delegate (EUR)

1989.00
Register now

Request Full Agenda

For the detailed agenda with a full breakdown of the individual sessions fill out this form.

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Contact us

Lydia Makori

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