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General Session - Live Streamed to Virtual Audience [clear filter]
Tuesday, October 26
 

9:00am CDT

Chairperson’s Opening Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Tuesday October 26, 2021 9:00am - 9:30am CDT

9:30am CDT

Fireside Chat: Essential Documents – Review the Conduct and Management of a Clinical Trial
Moderators
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →

Speakers
avatar for Azhar Bisle, MSM-HCA, BSc.

Azhar Bisle, MSM-HCA, BSc.

Clinical Compliance Manager, Clinical Operations, Arena Pharmaceuticals, Inc
Azhar Bisle is a Clinical Compliance Manager at Arena Pharmaceuticals, responsible for Clinical Trial Compliance, Trial Oversight, and providing cross-functional clinical support to all clinical staff. Azhar has worked with various Trial Master File systems, legacy paper to most eTMF... Read More →


Tuesday October 26, 2021 9:30am - 10:00am CDT

10:00am CDT

Everything You Need to Know About Audit Trails
Speakers
avatar for Gillian Gittens

Gillian Gittens

Director, e-Clinical Strategy & Solutions, TransPerfect
Gillian is Director of eClinical Strategy and Solutions for Trial Interactive, TransPerfect’s eClinical platform. A career Trial Master File and eTMF subject matter expert with over 20 years of experience, she has a wide range of experience across operations, implementation... Read More →


Tuesday October 26, 2021 10:00am - 10:30am CDT

11:00am CDT

When is the right time to Archive your TMF?
Now that we are working in a more fully digital world, we are faced with the new challenge of how to manage our electronic content and keep these records safe, secure, and accessible for their lifetime. This means that the electronic documents and data collected during trials needs to be maintained for 25 years or longer.
  • Have you mapped out a strategy for how this is going to be done?
  • What if your system changes, are you going to migrate and if so, how can you be sure to preserve the integrity of the data?
  • What if the software that generated your data is now obsolete, have you considered transforming?
The big question is always “When is the right time to move to an Archive”.

Speakers
avatar for Marion Mays

Marion Mays

Vice President, Expert Services and Consulting Solutions, PHLEXGLOBAL
Marion Mays in an industry leader in Information Management with over 28 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the... Read More →


Tuesday October 26, 2021 11:00am - 11:30am CDT

11:30am CDT

Panel Discussion: Risk-Based Approach to Periodic Review
Moderators
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

Speakers
avatar for Masoom Patel

Masoom Patel

Senior Clinical Document Management Specialist, Takeda
avatar for Traci Wendler

Traci Wendler

Sr. Manager, TMF Study Lead Line Head, Bristol-Myers Squibb
Traci has worked in Regulatory & Compliance for the past 16 years, focusing on clinical research trials, specifically the TMF for the last 10 years. Her career history includes working for 2 major pharmaceutical companies, a TMF vendor, the NIH and Stony Brook Research Foundation... Read More →
avatar for Christa Lewiski

Christa Lewiski

Associate Director, Records & Information Management (TMF Head), Akebia Therapeutics
Christa Lewiski is the TMF Head, Associate Director Records Information Management at Akebia Therapeutics, Inc. She is the owner of Akebia's TMF system and also responsible for all TMF processes. Christa has 20 years experience in TMF/clinical document management within the biopharmaceutical... Read More →


Tuesday October 26, 2021 11:30am - 12:15pm CDT

12:15pm CDT

eTMF Pep Talk
  • Simplifying the eTMF Experience
  • Brightening the Future of eTMF: AI + ML
  • Seeing the Entire eTMF Field of Play
  • Deepening your eTMF Bench

Speakers
avatar for Kevin Seeley

Kevin Seeley

Associate Director US Sales, IQVIA Technologies
Having spent the last 13 years in life sciences, Kevin has worked with globally mature sponsors such as Daiichi Sankyo, Boston Scientific, Zimmer Biomet & Nuvasive.More recently Kevin has dedicated his career towards consulting the life sciences industry – inclusive of biotechs... Read More →


Tuesday October 26, 2021 12:15pm - 12:30pm CDT

6:15pm CDT

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →


Tuesday October 26, 2021 6:15pm - 6:30pm CDT
 
Wednesday, October 27
 

9:00am CDT

Chairperson’s Opening Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Wednesday October 27, 2021 9:00am - 9:15am CDT

3:00pm CDT

Migration Best Practices
Speakers
avatar for Ashlyn Deshaies

Ashlyn Deshaies

Associate Director, Clinical and TMF Operations, TG Therapeutics, Inc.
Ashlyn Deshaies serves as the Associate Director of Clinical and TMF Operations at TG Therapeutics overseeing the planning and execution of TMF processes, quality reviews, and TMF scoped deliverables. Ashlyn has driven implementation TMF maintenance guidelines based on the "three... Read More →


Wednesday October 27, 2021 3:00pm - 3:30pm CDT

3:30pm CDT

Panel Discussion: Enhance Collaboration Between Sponsor, Sites, and CROs to Improve TMF Quality
Moderators
avatar for Azhar Bisle, MSM-HCA, BSc.

Azhar Bisle, MSM-HCA, BSc.

Clinical Compliance Manager, Clinical Operations, Arena Pharmaceuticals, Inc
Azhar Bisle is a Clinical Compliance Manager at Arena Pharmaceuticals, responsible for Clinical Trial Compliance, Trial Oversight, and providing cross-functional clinical support to all clinical staff. Azhar has worked with various Trial Master File systems, legacy paper to most eTMF... Read More →

Speakers
avatar for Caroline Nielson

Caroline Nielson

Manager, Records Management, Ultragenyx
avatar for Aryn Knight, BS, CCRP

Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research, Texas Heart Institute
Aryn Knight, CCRP, is Administrative Director at Texas Heart Institute, Center for Clinical Research in Houston, TX. She is a Certified Clinical Research Professional (CCRP) with more than 20 years of direct experience in clinical research in academia and hospital environments. Since... Read More →
avatar for Tonia Huggins

Tonia Huggins

Director, TMF Operations, Syneos Health
Tonia Huggins is a Director of TMF Operations at Syneos Health. Tonia has over 10 years dedicated TMF management experience that includes working with multiple CROs across various TMF platforms, process development and implementation, system migrations, and client relationships.At... Read More →
avatar for Seneca Harrison

Seneca Harrison

Vice President, Quality Clinical Research Inc.
Seneca Harrison is the Vice President of Operations and CEO of Quality Clinical Research, an expanding research facility catering to residents of the Midwest for nearly 20 years. Mr. Harrison has served as CEO since 2008 and has since made it his mission to diversify clinical trials... Read More →


Wednesday October 27, 2021 3:30pm - 4:15pm CDT

4:15pm CDT

Chairperson's Closing Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Wednesday October 27, 2021 4:15pm - 4:30pm CDT