Your health & safety come first! Due to the uncertainty caused by the COVID-19, IPEC Europe and APV took the difficult decision to postpone the 2020 Conference to September 2021 still in Frankfurt, Germany.
Register now to the IPEC Europe Excipient Conference webinar series for the usual insights on pharmaceutical excipients and IPEC Guides.
We look forward to welcoming you virtually!
PROGRAMME
Thursday 17 September 2020 and Friday 18 September 2020
10:00 - Technical Unavoidable Particles – A practical introduction to the IPEC guideline
Darek Lewin, J. Rettenmaier & Söhne (JRS Pharma) GmbH + Co KG, Germany
This webinar will explain the risk-based approach of the TUPP guideline and give examples on how information can be shared between excipient manufacturer and user.
16:00 - The Importance of Excipients in Continuous Manufacturing
David Schoneker, Black Diamond Regulatory Consulting, LLC, U.S
This presentation will provide an overview of the importance of understanding excipient properties and typical variability on products made using continuous manufacturing, and discuss what design criteria should be considered when developing excipients and selecting them for a CM formulation.
All presentations will be followed by a live Q&A session.
REGISTRATION FEES
| |
Members |
Non Members |
| one webinar |
60€ |
80€ |
| two webinars |
100€ |
140€ |
All registration fees are VAT excl.
Please note: "Members" refers to employees of IPEC Europe members based in Europe. If you are unsure of your status, please contact the IPEC Europe Secretariat: info@ipec-europe.org
CANCELLATION POLICY
The registration fee for the webinars is not reimbursable. Substitutions are accepted. Webinar participants who are unable to attend should inform the IPEC Europe Secretariat (info@ipec-europe.org) in writing and provide the name of the replacement, if applicable, no later than Tuesday 15 September 2020 eob.
Technical Unavoidable Particles – A practical introduction to the IPEC guideline
Darek Lewin, J. Rettenmaier & Söhne (JRS Pharma) GmbH + Co KG, Germany
ABSTRACT
The IPEC Technically Unavoidable Particle Profile Guide gives guidance for the communication between excipient makers and users about visibly different particles in excipients. These types of particles have always been present in excipients and they are often known to the excipient manufacturer, have been previously investigated, and pose no risk to patient safety. With current technologies, these particles are technically unavoidable and cannot be eliminated in the finished excipient. This lecture will explain the risk-based approach of the guideline and give examples how information can be shared between excipient manufacturer and user.
LEARNING OBJECTIVES
- Summary of the content of the IPEC guideline
- Practical implementation with examples of TUP in common excipients
- Differentiation to objectionable particles resulting from contamination or adulteration
The Importance of Excipients in Continuous Manufacturing
David Schoneker, Black Diamond Regulatory Consulting, LLC, U.S
ABSTRACT
Continuous Manufacturing (CM) involves the continuous feeding of input materials into, transformation of in-process materials within, and removal of output materials from a system. Therefore, the consistency of excipient properties to be feed into these processes is of great importance in determining appropriate formulation and process control strategies. In addition, typically there is a need to limit the number of feeders in a continuous manufacturing process which means that the number of excipients may need to be limited as well which means that there will be certain advantages which can be achieved from formulating with high performance excipients, excipient mixtures or co-processed excipients which are designed for purpose. This presentation will provide an overview of the importance of understanding excipient properties and typical variability on products made using continuous manufacturing. There will also be a discussion concerning what design criteria should be considered when developing excipients and selecting them for a CM formulation. The developing regulatory landscape concerning CM and appropriate excipients (including novel excipients) for use in CM will also be discussed.
LEARNING OBJECTIVES
- A high-level overview of continuous manufacturing, including status for ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline.
- Examples of potential problems with excipients used in continuous manufacturing
- Discuss on current and future excipient needs to support continuous manufacturing.
- Regulatory perspective on the use of continuous manufacturing for pharmaceutical products.
