500 industry specialists from manufacturing companies, suppliers, and regulatory agencies gathered 28 September through 1 October at the Palais de Congres to exchange knowledge and ideas during educational seminars, workshops, networking sessions, and hands-on training.
Delegates attending the “PQLI - Global Realization and Implementation of the ICH Quality Vision” session had the opportunity to hear from senior regulators and industry leaders about latest developments in the implementation of ICH Q8, Q9, and Q10. There was a “hot off the press” briefing on the joint European Medicines Agency (EMEA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on QbD (held just the day before), and workshops on current and new areas of interest within PQLI. Attendees heard the latest news about the proposed ICH training program from regulatory members of the ICH Implementation Working Group, including Emer Cooke, EMEA (UK), Yukio Hiyama, National Institute Health Sciences (Japan), Susanne Keitel, EDQM (Council of Europe), Jacques Morénas, AFSSAPS (France), and Jean-Louis Robert, Laboratoires National de Sante (Luxembourg).
Technology also played a pivotal role in the event. For the first time in Europe, select educational sessions were recorded -- thus allowing the knowledge and experiences of the event to reach a wider audience -- and are now available as downloadable webinars . Recorded sessions include Biological Products Manufacturing Challenges - Now and in the Future; Business Excellence Concepts, Process Development Improvements; Occupational Exposure Issues with Large and Small Molecules; and Risk-based Implementation of Single-use Systems. In addition, many of the seminars made use of voting technology to poll delegates, getting instant feedback on a number of questions posed by the audience.
In addition, it was the first time ISPE and INTERPHEX partnered to host a European vendor exhibition and a variety of networking receptions that allowed exhibit attendees to engage and network with fellow seminar delegates, vendors, and colleagues.
Delegates attending the “PQLI - Global Realization and Implementation of the ICH Quality Vision” session had the opportunity to hear from senior regulators and industry leaders about latest developments in the implementation of ICH Q8, Q9, and Q10. There was a “hot off the press” briefing on the joint European Medicines Agency (EMEA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on QbD (held just the day before), and workshops on current and new areas of interest within PQLI. Attendees heard the latest news about the proposed ICH training program from regulatory members of the ICH Implementation Working Group, including Emer Cooke, EMEA (UK), Yukio Hiyama, National Institute Health Sciences (Japan), Susanne Keitel, EDQM (Council of Europe), Jacques Morénas, AFSSAPS (France), and Jean-Louis Robert, Laboratoires National de Sante (Luxembourg).
Technology also played a pivotal role in the event. For the first time in Europe, select educational sessions were recorded -- thus allowing the knowledge and experiences of the event to reach a wider audience -- and are now available as downloadable webinars . Recorded sessions include Biological Products Manufacturing Challenges - Now and in the Future; Business Excellence Concepts, Process Development Improvements; Occupational Exposure Issues with Large and Small Molecules; and Risk-based Implementation of Single-use Systems. In addition, many of the seminars made use of voting technology to poll delegates, getting instant feedback on a number of questions posed by the audience.
In addition, it was the first time ISPE and INTERPHEX partnered to host a European vendor exhibition and a variety of networking receptions that allowed exhibit attendees to engage and network with fellow seminar delegates, vendors, and colleagues.
