Press Room

IPAC-RS FDA Roundtable

Start
Monday, November 02, 2020 - 10:30
End
Monday, November 02, 2020 - 10:30
Location: online
IPAC-RS Logo | Hovione

 

 

On November 2, 2020, (10:30 AM – 12:00 PM US ET) IPAC-RS is hosting a webinar with FDAA Conversation with the FDA: Perspectives in the Time of COVID-19. Carla Vozone, Vice President, Pharmaceutical Development & Licensing at Hovione is a panelist in this discussion.

 

Click Here to Register Now

 

 

The IPAC-RS Regulatory Roundtable Series is focused on bringing together leaders in the Orally Inhaled and Nasal Drug Product (OINDP) space. Invited guests will include regulators, industry thought leaders, business leaders, academics, patient groups and others who comprise the OINDP “ecosystem.”

PANELISTS

  • Richard Lostritto, Associate Director for Science in Office of Policy for Pharmaceutical Quality  (OPPQ)/OPQ/CDER/US Food and Drug Administration
  • Brian J. Hasselbalch, Deputy Director, OPPQ/OPQ/CDER/US Food and Drug Administration
  • Carla Vozone, Vice President, Pharmaceutical Development & Licensing, Hovione
  • Martin J. Oliver, Senior Vice President, Generic Programmes, Vectura Ltd.

MODERATOR

  • Mary Devlin Capizzi, IPAC-RS Secretariat and Legal Counsel; Partner, Faegre Drinker Biddle & Reath LLC

 

Click Here to Register Now

 

 

Registration is required to attend the webinar

After registering, individuals will receive a confirmation email containing a custom link* and additional information about joining the webinar.

 

Questions?

Please contact Mrs. Dede Godstrey at the IPAC-RS Secretariat at Dede.Godstrey@FaegreDrinker.com 

 

 

 

Click here to view Webinar Roundtable Flyer

Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024