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Clinical Trial Transparency-Clinical Trial Disclos [clear filter]
Monday, June 27

8:30am EDT

#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.


Jennifer Lentz


Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts


Jennifer Lentz

Consultant, Global Informed Business Lead, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Business Lead at Eli Lilly and Company for the last 4 years. She has been involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer... Read More →

avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Pamela Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

1:30pm EDT

#149: EMA's Publication Policy 0070: Best Practices for Implementation
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.


Robert Paarlberg, MS


Helle M Gawrylewski, MA

avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB... Read More →

avatar for Helle Gawrylewski

Helle Gawrylewski

Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40... Read More →

Monday June 27, 2016 1:30pm - 2:15pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop
Tuesday, June 28

10:30am EDT

#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.


Martha Ann Brumfield, PhD


FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD

avatar for Martha Brumfield

Martha Brumfield

President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory... Read More →

avatar for ShaAvhree Buckman-Garner

ShaAvhree Buckman-Garner

Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the... Read More →
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →

Tuesday June 28, 2016 10:30am - 11:30am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum
Wednesday, June 29

10:30am EDT

#313: The Future of Clinical Research Data: 2020 and Beyond
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.


Wayne R. Kubick, MBA


Dave Evans, MS

Armando Oliva, MD

Kenneth A. Getz, MBA

avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

avatar for Dave Evans

Dave Evans

Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Armando Oliva

Armando Oliva

President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#341: eTMF: Selection, Implementation, and What's Next?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will walk through the steps from vendor selection to global implementation of an eTMF software and associated services - both as a general approach and a case study for a top ten pharmaceutical company. It will elaborate on the various workstreams established to ensure success.

Learning Objectives

Describe the hurdles to successful global implementation of an eTMF; Discuss the importance of a robust TMF structure; Recognize that an eTMF is not about the software, its about the processes and workflows.


Karen Jane Roy, MPharm


eTMF: Challenges and Possible Solutions
Laxman Kumar Jakkala, SR, PhD

Global Implementation of a Full Service Provision eTMF Software and Services: A Case Study
Martina M Duevel, DrSc

avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal, United Kingdom
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 →


Martina Duevel

Senior GCPM ONC, eTMF Process Owner Representative, Bayer Pharma AG
Dr. Martina Duevel eTMF Process Owner Representative, Bayer In the pharmaceutical industry for 16 years with roles in QA and Clinical Project Management. Project Lead for eTMF implementation and maturation, and Process Owner Representative for internal oversight and vendor govern... Read More →

Laxman Jakkala

Director, Global Quality Assurance, MakroCare

Wednesday June 29, 2016 2:00pm - 3:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session