50+ speakers from more than 35 companies, this year’s Summit boasts the most diverse faculty yet!
Evelin Baez
Senior Clinical Operations Specialist BD
Wendy Beeby
Director, Clinical Document Management, Inspection Readiness and Trial Support TAKEDA
Tatsiana Brady
Senior Manager, Audit and Inspection Readiness, Specialty Clinical Development and Global Medical Affairs TEVA
Kristen Bretzius
Manager, TMF Governance TEVA PHARMACEUTICALS
June Buchanan
Director, Clinical Operations TESARO
Deborah Castellana
Associate Director, Regulatory Affairs, Essential Document Management CELGENE
Jessica Chamberlain
Records Analyst, Central Medical Files ASTELLAS
Dorte Frejwald Christiansen
Competency Development Specialist NOVO NORDISK
Dawn Clowes
Manager, Regulatory TMF BIOGEN
Grace Crawford
Global Head of Clinical Quality and Compliance ASTRAZENECA
Sonja Davis
Associate Senior QA Consultant, QA-Product Research and Development ELI LILLY
Brian Dempster
Director, Clinical Affairs ENDOLOGIX
Donna Dorozinsky
President JUST IN TIME GCP
Martina Duevel
Systems Excellence Project Leader BAYER
Liz Farrell
Senior Manager, TMF BIOGEN
Paul Fenton
Founder and CEO MONTRIUM
Karen Freid
Essential Document Specialist MERCK
Patty Fulton
Quality Consultant, Trial Master File ELI LILLY
Gillian Gittens
Customer Success Manager IQVIA
Rebecca Halbur
Senior Manager, TMF Systems BIOGEN
Nick Hargaden
Associate Director, Clinical Systems AGIOS
Etienne Hinton
Clinical Trial Coordinator DUKE CLINICAL RESEARCH INSTITUTE
Aryn Knight
Administrative Director, Center for Clinical Research TEXAS HEART INSTITUTE
Hobson Lopes
Manager, Clinical Archive REGENERON PHARMACEUTICALS
Alex Markiel
Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations PHARMACYCLICS
James Martin
Director, TMF Operations – CDS SYNEOS HEALTH
JP Miceli
Associate Director of Document Management ADVANCED CLINICAL
Thomas Miller
Product Delivery Consultant - Design Hub ELI LILLY
Lisa Mulcahy
Owner and Principal Consultant MULCAHY CONSULTING
Curran Murphy
Director, Clinical Operations DECIPHERA PHARMACEUTICALS
Laura Naranjo
Associate Director, TMF Operations DAIICHI SANKYO
Vinay Parachuri
Practice Head — Life Sciences PHARMA TEK SOLUTIONS
Marie-Christine Poisson-Carvajal
Senior Director, Head of TMF and Registry Operations PFIZER
Minette Pugh
Advisor, Quality Systems and Compliance Management ELI LILLY
Lori J. Ridge
Senior TMF Project Manager MYLAN PHARMACEUTICALS
Karen Roy
Chief Strategy Officer PHLEXGLOBAL
Jay Russak
Clinical Team Lead DICENRA PHARMACEUTICALS
Barry Sacks
Chief Technology Officer PHLEXGLOBAL
Nicole Sheetz
Director, Clinical Design, Delivery and Analytics ELI LILLY
Supriya Shoroff
Head of TMF Operations AMAG PHARMACEUTICALS
Shannon Simpson
Trial Master File and Institutional Review Board Specialist PATH
Jay Smith
Senior Director, Product, Trial Interactive TRANSPERFECT
Joaquin Sosa
Director, TMF Operations SYNEOS HEALTH
Bryan Souder
Director, TMF Head MERCK
Perry Steinberg
GM & VP, Product MEDIDATA, a Dassault Systèmes company
Kyle Stephenson
Clinical Product Manager VEEVA
Jamie Toth
Director and Head of TMF Operations DAIICHI SANKYO
Wendy Trimboli
Former Director TMF Operations, Inspection and Strategy JUST IN TIME GCP
Allison Varjavandi
Director, Central Medical Files ASTELLAS
Anne-Mette Varney
Principal Competency Development Specialist NOVO NORDISK
Stephanie Viscomi
Associate Director, TMF Compliance and Education ALEXION
Debra Wells
Sr. Manager, Global Regulatory Systems and Process Management EISAI
Karen Whitson
Assistant Director, Clinical Documentation Center ABBVIE
Keith Win
Senior Business Analyst, TMF Operations DAIICHI SANKYO
Three days, four workshops, six tracks, and endless amounts of information.
This three-day Summit in the Sunshine State offers attendees premier networking opportunities, access to the TMF community, and endless amounts of educational information to bring back to their teams. Summit participants return to work informed, equipped, and inspired to guide their organization’s TMF to its full potential! Focuses and new features of this year’s program include:
- Four workshops for varying experience-levels
- Inspection experience showcase
- Functional area collaboration
- TMF operations
- Quality and completeness
- eTMF/technology enhancements
- Partnerships
- Inspection readiness
Bridge the Gap Between Sponsors and CROs
Moderator:
Dawn
M.
Niccum
, Senior Director of QA and Compliance
INSEPTION GROUP
Panelists:
Alex
Markiel
, Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations
PHARMACYCLICS
Curran
Murphy
, Director, Clinical Operations
DECIPHERA PHARMACEUTICALS
Stephanie
Viscomi
, Associate Director, TMF Compliance and Education
ALEXION
View Agenda
Sponsors
