BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T095623Z UID:9ac1156b-d004-4885-9291-004b70c03d25 DTSTART:20211018T080000 DTEND:20211019T080000 CLASS:PRIVATE DESCRIPTION:
ExL Pharma&rsquo\;s European Trial Master File Summit contin ues to be the #1 source of information and replicable best practices in th e life science industry. The quality and immediate relevance of topics are rivalled only by the calibre and zeal of our expert speaking faculty as w ell as the enthusiasm of participants at the event each year &mdash\; and there is good reason for this.
\n\nThis conference is by and for TMF &trade\; professionals who play an active role in the identification and d evelopment of topics prior to the event. This event features a balance of:
\n\nAt the summ it\, the interaction among this group of like-minded learners and leaders generates an unparalleled exchange of ideas and adaptation of strategies a nd tools. This October\, 120+ participants\, ranging from beginner to expert\, will actively delve into principles\, discuss pitfal ls\, discover strategies\, and vet best practices suited to their TMF need s.
\n\nThe 40+ speakers of 6th European TMF Summit are eager to conf er the lessons they have learned on a wide yet cohesive range of topics ta ilored to your critical need for information\, tools\, savvy and professio nal development that will prepare you to return to work to
\n\nThis conference is designed for rep resentatives from pharmaceutical\, biotech\, medical device and clinical r esearch companies with responsibilities in the following areas:
\n\nThis conference is also of interest to:
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8:00 | \n\n Registration and Continental Breakfas
t \n\n  \;\n | \n |
8:45 | \n\n Co-Chairs&rsqu
o\; Opening Remarks \n\n
 \; \n\n Karen Roy
\, Senior Vice President\, Client Solutions\, PH
LEXGLOBAL \n \n Vittoria Sparacio\, Head\, Clinical Documentation Ope rations\, GLAXOSMITHKLINE | \n |
9:00 | \n\n Analyse on GCP Compliance in Relation to Trial Master File for Cont
ent\, Management\, Archiving\, Audit and Inspection of Clinical Trials \n\n \n \n\n
 \; \n | \n |
9:45 | \n\n Consider Best Practices to Prevent Critical Findings \n\n \n \n\n
K
aren Roy\, Senior Vice President\, Client Solutions\, | \n |
1 0:30 | \n\n Networking Bre
ak \n\n  \;
div>\n | \n |
11:00 | \n\n Ensure a Hig
h-Quality TMF System Through Positive CRO/Sponsor Interactions and Oversig
ht \n\n \n \n\n
Jamie Marie Toth\, Head of TMF Ope
rations\, DAIICHI SANKYO \n | \n |
11:45 | \n\n Transition From TMF to eTMF: Tips and Tools for Minimizing the Pain
s of Change \n\n
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Pat
ricia Santos-Serrao\, RAC\, Director\, Clini
cal and Regulatory Solutions Pharmaceutical\, Blood and Biologics\, <
strong>MASTERCONTROL
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12:45 | \n\n Networking
Luncheon \n\n &nb
sp\; \n | \n |
13:45 | \n\n \n \n\n
Claudia Pan
itz\, Head Regulatory Readiness and Archival/ GDO\, \n
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14:30 | \n\n Panel Utilise an eTMF System to Monitor All Aspects of the TMF Process\, Ve
ndors\, Quality and Clinical Research Sites \n\n \n \n\n
Jeannette Dixon\, Associate
Director\, Clinical Operations Quality Oversight\, BIOGEN \n \n Jeff Pilot\, Senior Clinical Project Manager\, NORGIN E | \n
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15:15 | \n||
15:45 | \n\n Take a Behind-the-Scenes Tou
r of Active eTMF Management
div>\n\n \n
\n\n
Franciska Darmer\, \n | \n |
16:30 | \n\n Address TMF Strategy Considerations f
or Essential Safety Documents to Be Compliant With Article 57 \n\n \n \n\n
Lucy Ha
mpshire\, Director\, Medicines Quality Organisation - Europe<
/em>\, ELI LILLY \n \n Jennifer Maier\, Associate Director\, R&\;D Quality Compliance\, ALEXION PHARMACEUTICALS | \n |
17:15 | \n\n Day One Concludes \n | \n
tr>\n
8:30 | \n\n Registration Opens and Continental Brea
kfast \n\n  \
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9:00 | \n\n Co-Chairs&
rsquo\; Recap of Day One \n\n  \; \n\n Kare
n Roy\, Senior Vice President\, Client Solutions\, \n \n Vittoria Sparacio\, Head\, Clinical Documentatio n Operations\, GLAXOSMITHKLINE | \n |
9:15 | \n\n Oversee an eTMF Process for a CRO-Run Study With Proven Proces
ses and Tools \n\n
Kathie Clark
\, Vice President\, Product Management\, WINGSPAN TECHNOL
OGY \n \n | \n
tr>\n |
10:00 | \n\n Case Study
CASE STUDY: Bolster eTMF System Compliance and Data Quality Though Metrics
\, Dashboards and Automation <
/div>\n\n \n \n\n
Timothy Raffer
ty\, eTMF Quality and Metrics Manager\, ROCHE \n | \n \n |
10:45 | \n\n Networking Break \n\n  \; \n | \n
tr>\n |
11:15 | \n\n Case Study
Apply a Risk-Based Approach to Your TMF Process \n\n \n \n\n
Ruth Coll\,
Senior Clinical Program Manager\, TRIZELL \n | \n |
12:00 | \n\
n Assure TMF System Quality Through the Engagem
ent of People and Establishment of Processes and Systems \n\n \n \n\n
Dorte Frejwald Chris
tiansen\, TMF Lead\, Principal Consultant\, NNIT
\n | \n
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12:45 | \n\n Networking Luncheon \n\n  \; \n |
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13:45 | \n\n Case Study Define\, Monitor and Remain Inspection-Ready \n\n \n \n\n
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14:30 | \n\n Case Study Document and Content Management Part of a Robust Quality Management Sys
tem \n\n \n
Scott McCulloch\, <
em>Associate Director\, Development Sciences Quality\, BIOMAR
IN EUROPE \n
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15:15 | \n\n Networking Break \n\n  \; \n
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15:45 td>\n | \n Understand the Impac
t and Showcase the Process of Documentation Within the TMF Process \n\n \n \n\n
Nancy Meyerson&ndash\;Hess\, Associate Pa
rtner\; Former Head of Clinical Operations and Compliance\, A
DMEDICUM BUSINESS FOR PATIENTS\; GRUNENTHAL \n | \n |
16:30 | \n\n Ensure TMF Completeness <
/small> \n\n \n \n\n
Wendy Ko&cced
il\;\, Senior Manager Clinical Compliance\, GILE
AD SCIENCES \n
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17:15 td>\n | \n Conference Concludes
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