BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 16.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:STANDARD DTSTART:16011104T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=11 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 END:STANDARD BEGIN:DAYLIGHT DTSTART:16010311T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYMONTH=3 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT CLASS:PUBLIC CREATED:20191127T123605Z DESCRIPTION:Event includes a light lunch\n \nAgenda: \n12:30 - 13:00 Regist ration/Light Lunch\n \n13:00 - 13:15 Welcome\nDr. Janina Lehmann – Sr. D irector Technical Customer Support NA & Europe\n \n13:15 –14:15 Navigati ng the regulatory landscape for Drug Delivery – with focus on the new EU MDR and US regulations\nDr. Bettine Boltres – Principal Scientific Affa irs\, Packaging & Delivery Systems EU\nAs baseline quality requirements\, biologic drugs must meet the pharmaceutical quality standards as described in pharmacopeias and prove to be safe for the intended purpose of use. Be yond that\, regulatory agencies are increasingly focusing on quality risk management in development\, manufacturing and post-approval changes of ste rile drug products and injectable devices. Pharmaceutical companies can be nefit from employing an outsourced partner understanding the primary packa ging\, device\, analytical and regulatory requirements along the drug deve lopment process and providing integrated solutions.\n \n14:15 – 15:15 Th e Impact of Yesterday’s Packaging Components on Manufacturing and Produc t Quality of Today’s Drug Products and Tomorrow’s Novel Applications\n Dr. Björn Henze\, Manager Technical Customer Support Europe\nThe sensitiv ities of biologic drugs demand greater quality in packaging systems in ord er to mitigate risks associated with the various packaging components. Leg acy packaging components may no longer fit the requirements needed to ensu re product safety and efficacy of these complex drugs throughout the shelf life. Containment and delivery systems must exhibit the required chemical \, physical and performance properties to ensure product quality\, be comp atible with fill and finish processing equipment and provide necessary fun ctional performance during administration.\n \n15:15 – 14:45 Break and E xperience West’s New Product Innovations\n \n14:45 – 15:45 CSTD impact on Container Closure Systems\nDr. Janina Lehmann – Sr. Director Technic al Customer Support NA & Europe\nClosed system transfer devices (CSTD) are a supplemental engineering control designed to reduce occupational exposu re of hazardous drugs and are currently implemented in accordance with evo lving regulations. As the CSTD landscape continues to develop\, drug produ ct compatibility and device performance testing should be performed. Learn how to mitigate the risk of drug product incompatibility with CSTD.\n \n1 5:45 – 15:15 Interactive Discussion\nOpportunity for further informal di scussions with West experts and various colleagues from the pharmaceutical industry.\n \n15:15 – 15:30 Wrap-up\n DTEND;TZID="Eastern Standard Time":20200204T093000 DTSTAMP:20191127T123605Z DTSTART;TZID="Eastern Standard Time":20200204T063000 LAST-MODIFIED:20191127T123605Z LOCATION:Molitor\, 13 Rue Nungesser et Colii\, 75016 Paris\, France PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Educational Series in Paris\, France TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000030B10760F4A4D501000000000000000 010000000868CBB2AD651C642A4F3F5461A2E59B5 X-ALT-DESC;FMTTYPE=text/html:
Event includes a light lunch
Agenda:
12:30 - 13
:00 Registration/Light Lunch
13
:00 - 13:15 Welcome
Dr. Janina Lehmann –\; Sr. Director Technical C
ustomer Support NA &\; Europe
13:15 –\;14:15 Navigating the regulatory landscape for Drug Delivery
8211\; with focus on the new EU MDR and US regulations
As baseline quality requirements\, biologic drugs must meet the pharmaceut
ical quality standards as described in pharmacopeias and prove to be safe
for the intended purpose of use. Beyond that\, regulatory agencies are inc
reasingly focusing on quality risk management in development\, manufacturi
ng and post-approval changes of sterile drug products and injectable devic
es. Pharmaceutical companies can benefit from employing an outsourced part
ner understanding the primary packaging\, device\, analytical and regulato
ry requirements along the drug development process and providing integrate
d solutions.
14:15 –\; 15:15 T
he Impact of Yesterday’\;s Packaging Components on Manufacturing and
Product Quality of Today’\;s Drug Products and Tomorrow’\;s Nove
l Applications
Dr. Bjö\;rn Henze\
, Manager Technical Customer Support Europe
The sensitivities of biologic drugs demand greater quality in packaging
systems in order to mitigate risks associated with the various packaging
components. Legacy packaging components may no longer fit the requirements
needed to ensure product safety and efficacy of these complex drugs throu
ghout the shelf life. Containment and delivery systems must exhibit the re
quired chemical\, physical and performance properties to ensure product qu
ality\, be compatible with fill and finish processing equipment and provid
e necessary functional performance during administration.
15:15 –\; 1
4:45 Break and Experience West̵
7\;s New Product Innovations
14:45 –\; 15:45 CSTD impact on Container Closure Systems
Dr. Janina Lehmann –\; Sr. Director Technical
Customer Support NA &\; Europe
Closed
system transfer devices (CSTD) are a supplemental engineering control desi
gned to reduce occupational exposure of hazardous drugs and are currently
implemented in accordance with evolving regulations. As the CSTD landscape
continues to develop\, drug product compatibility and device performance
testing should be performed. Learn how to mitigate the risk of drug produc
t incompatibility with CSTD.
15:45 –\; 15:15 Interactive Discussion
Opportunity for further informal discussions with West experts and variou
s colleagues from the pharmaceutical industry.
15:15 –\; 15:30 Wrap-up