Pharma 2025 _ Event Postponement

We would like to inform you that due to unforeseen circumstances beyond the organizer control, the "12th Edition of the Global Conference on Pharmaceutics and Novel Drug Delivery Systems" (Pharma-2025), originally scheduled for March 13-15, 2025 | Hybrid Event has been postponed. The updated dates and venue are September 11-13, 2025 | Valencia, Spain. For more details, please visit: https://pharmaceuticsconference.com/

Your registration can be transferred to the next edition, if you have already confirmed your participation at the event.

For further details, please contact us at pharmadds@magnusconference.com or call + 1 (702) 988 2320.

HYBRID EVENT: You can participate in person at Rome, Italy or Virtually from your home or work.
Richard Denk, Speaker at Drug Delivery Conferences
Richard Denk
SKAN AG, Switzerland
Title : EU GMP annex1 barrier system and PIC/s annex 2A on cell and gene therapy

Abstract:

The new EU GMP Annex 1 for sterile Manufacturing was published in August 2022. The industry does now have one year time for implementation. Exception loading and unloading for the Lyophilization which provides an implementation time of two years. What does this mean for sterile Manufacturing but also for the Manufacturing of Cell and Gene Products. For Cell and Gene (ATMPs) the PIC/s published in 2021 the Annex 2A for ATMPs and it might be that PIC/s link their Annex 1 with the Annex 2 A which would mean higher requirements also for the manufacturing of ATMPs. The presentation will be focused on Contamination Control Strategy, Barrier Systems as those on of the major new areas to consider.  

Audience Take Away Notes:

  • Comparison between EU GMP Annex 1 and PIC/s Annex 2A
  • What to consider when implementation a CCS
  • What is the right Barrier Solution for my process

Biography:

Richard Denk is working at the company SKAN AG, headquartered in Allschwil  in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard was on the Annex 1 and PIC/s Annex 2 commenting team of the ISPE, Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard has spent more than 20 years with the subject on Aseptic Processing and  highly active / highly hazardous substances and has developed the containment pyramid.

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