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17: Community Rounds [clear filter]
Monday, June 25
 

1:45pm EDT

#133: DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity
Component Type: Forum

Seating is limited.
Join DIA GCP and QA Community for a round table discussion tied to session # 111 Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity (Monday, June 25th)

To include special guests from the session: Nareen Katta and Gene Vinson.

Chair

Terry Katz, MS

Monday June 25, 2018 1:45pm - 2:45pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

1:45pm EDT

#134: DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination
Component Type: Forum

Seating is limited.
Join DIA MW Community for a round table discussion tied to session # 112 Scientific Communication Key Message Development, Management, and Dissemination (Monday, June 25th)

To include special guests from the session: David Clemow, Kristine Joliffe, and Wesley Portegies.

Chair

David B. Clemow, PhD

Speakers
avatar for David Clemow

David Clemow

Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →

Monday June 25, 2018 1:45pm - 2:45pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum
 
Tuesday, June 26
 

9:30am EDT

#221: DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs
Component Type: Forum

Seating is limited.
Join DIA RA Community for a round table discussion tied to session # 210 Artificial Intelligence: The Future of Regulatory Affairs (Tuesday, June 26th)

To include special guests from the session: Linda Bowen, Oliver Steck, Dany De Grave, and Bakul Patel.

Chair

Linda Bowen

Tuesday June 26, 2018 9:30am - 10:30am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

9:30am EDT

#222: DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors
Component Type: Forum

Seating is limited.
Join DIA PE Community for a round table discussion tied to session # 145 New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors (Monday, June 25th)

To include special guests from the session: Katie Jensen, Kristen Voorhees, Alice Bast, and Suzanne Schrandt.

Chair

Mary Stober Murray, MBA

Speakers
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →

Tuesday June 26, 2018 9:30am - 10:30am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

2:00pm EDT

#269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars
Component Type: Forum

Seating is limited.
Join DIA RA Community for a round table discussion tied to session # 212 Global Regulatory Strategies for Biosimilars (Tuesday, June 26th)

To include special guests from the session: Oxana Illiach, Agnes Klein, and Yatika Kohl.

Chair

Linda Bowen

Tuesday June 26, 2018 2:00pm - 3:00pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

3:15pm EDT

#270: DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications
Component Type: Forum

Seating is limited.
Join DIA MW Community for a round table discussion tied to session # 227 Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications (Tuesday, June 26th)

To include special guests from the session Maghavi Gidh-Jain and Tim Wolfe.

Chair

David B. Clemow, PhD

Speakers
avatar for David Clemow

David Clemow

Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →

Tuesday June 26, 2018 3:15pm - 4:15pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

3:15pm EDT

#271: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions
Component Type: Forum

Seating is limited.
Join DIA CSP Community round table discussion tied to session # 251 Risk Management: New Directions (Tuesday, June 26th)

To include special guests from the session: Helen Kathryn Edelberg and Mark Perrott.

Chair

Catherine Baldridge, MS

Speakers
avatar for Catherine Baldridge

Catherine Baldridge

Clinical Safety and Pharmacovigilance, PV Compliance, Indivior

Tuesday June 26, 2018 3:15pm - 4:15pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

4:30pm EDT

#295: DIA Devices and Diagnostics Community Round Table Discussion: Navigating the Regulatory Landscape of Drug-Device Combination Products
Component Type: Forum

Seating is limited
Join DIA D&D Community for a round table discussion tied to session # 263 Navigating the Regulatory Landscape of Drug-Device Combination ProductS (Tuesday, June 26th)

To include special guests from the session: Kirsten Paulson and Rebecca Lipsitz.

Chair

Kerri-Anne Mallet, MBA

Tuesday June 26, 2018 4:30pm - 5:30pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

4:30pm EDT

#296: DIA Medical Writing Community Round Table Discussion: CTD Regulatory Defense Strategies - How Best to Prepare Your Response to Health Authority Queries
Component Type: Forum

Seating is limited
Join DIA MW Community for a round table discussion tied to session # 256 CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries (Tuesday, June 26th).

To include speacial guests from the session: Frank Hubbard, Julia Forjanic, and Steve Sibley.

Chair

David B. Clemow, PhD

Speakers
avatar for David Clemow

David Clemow

Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →

Tuesday June 26, 2018 4:30pm - 5:30pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum
 
Wednesday, June 27
 

8:00am EDT

#319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone
Component Type: Forum

Join DIA CSP Community round table discussion tied to session # 277 Pharmacovigilance: No Longer Going it Alone (Tuesday, June 26th)

To include special guests from the session: Alan Hochberg and Amit Bhattacharyya.

Chair

Catherine Baldridge, MS

Speakers
avatar for Catherine Baldridge

Catherine Baldridge

Clinical Safety and Pharmacovigilance, PV Compliance, Indivior

Wednesday June 27, 2018 8:00am - 9:00am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

8:00am EDT

#320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels
Component Type: Forum

Seating is limited
Join DIA PE Community for a round table discussion tied to session # 258 Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels (Tuesday, June 26th)

To include special guest from the session: Hollie Schmidt

Chair

Laura Kolaczkowski

Wednesday June 27, 2018 8:00am - 9:00am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

9:30am EDT

#324: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance
Component Type: Forum

Seating is limited
Join DIA CSP Community round table discussion tied to session # 276 Patient Engagement in Pharmacovigilance (Tuesday, June 26th)

To include special guests from the session: Meredith Smith and David Blaser.

Chair

Catherine Baldridge, MS

Speakers
avatar for Catherine Baldridge

Catherine Baldridge

Clinical Safety and Pharmacovigilance, PV Compliance, Indivior

Wednesday June 27, 2018 9:30am - 10:30am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

9:30am EDT

#325: DIA Clinical Data Management Community Round Table Discussion: The Letter and Spirit of Risk-Based Monitoring - How to Creatively Implement the RBM and Unlock the Potential of the Team
Component Type: Forum

Seating is limited
Join DIA CDM Community round table discussion tied to session # 287 The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement the RBM and Unlock the Potential of the Team (Tuesday, June 26th)

To onclude special guests from the session: Johann Proeve and Teresa Ancukiewicz.

Chair

Peter Stokman, MSc

Wednesday June 27, 2018 9:30am - 10:30am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

1:00pm EDT

#352: DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines
Component Type: Forum

Seating is limited
Join DIA CP Community round table discssion tied to session # 309 Evolution and Harmonization of First-in-Human Guidelines (Wednesday, June 27th)

To include special guest from the session M.P. Thijs Van Iersel.

Chair

Beatrice Setnik, PhD

Speakers
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →

Wednesday June 27, 2018 1:00pm - 2:00pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

1:00pm EDT

#353: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less
Component Type: Forum

Seating is limited
Join DIA CSP Community round table discussion tied to session # 301 Automation in Pharmacovigilance: Doing More With Less (Wednesday, June 27th)

To include special guests from the session: Masha Hoffey and Axel Hagel.

Chair

Catherine Baldridge, MS

Speakers
avatar for Catherine Baldridge

Catherine Baldridge

Clinical Safety and Pharmacovigilance, PV Compliance, Indivior

Wednesday June 27, 2018 1:00pm - 2:00pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

3:00pm EDT

#378: DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products
Component Type: Forum

Seating is limited
Join DIA Devices and Diagnostics Community for a round table discussion tied to session # 314 What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products (Wednesday, June 27th)

To include special guests from the session: Anthony Genovese, Alexander Varond, Darin Openheimer and KerriAnne Mallet.

Chair

Kerri-Anne Mallet, MBA

Wednesday June 27, 2018 3:00pm - 4:00pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

3:00pm EDT

#379: DIA Clinical Trial Disclosure and DIA Medical Communication Communities' Round Table Discussion: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program
Component Type: Forum

Seating is limited
Join DIA CTD and MC Communities round table discussion tied to session # 334 Clinical Trial Results Disclosure: What Have We Learned from EMA Policy 0070 Implementation and ClinicalTrials.gov Postings? (Wednesday, June 27th)

To include special guests from the session: Robert Paarlberg, Olivia Shopshear, and Ann Witt.

Chair

Robert Paarlberg, MS

Speakers
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 →

Wednesday June 27, 2018 3:00pm - 4:00pm EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum
 
Thursday, June 28
 

8:00am EDT

#401: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management: Artificial Intelligence - A Disruptive Journey for Pharmacovigilance
Component Type: Forum

Seating is limited
Join DIA CSP Community round table discussion tied to session # 382 Artificial Intelligence: A Disruptive Journey for Pharmacovigilance (Wednesday, June 27th)

To include special guest from the session: Glenn Carroll.

Chair

Catherine Baldridge, MS

Speakers
avatar for Catherine Baldridge

Catherine Baldridge

Clinical Safety and Pharmacovigilance, PV Compliance, Indivior

Thursday June 28, 2018 8:00am - 9:00am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum

8:00am EDT

#402: DIA Patient Engagement Community Round Table Discussion: Addressing the Elephant in the Room - A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement
Component Type: Forum

Seating is limited
Join DIA PE Community for a round table discussion tied to session # 336 Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement (Wednesday, June 27th)

Chair

Mary Stober Murray, MBA

Speakers
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →

Thursday June 28, 2018 8:00am - 9:00am EDT
Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  17: Community Rounds, Forum
 
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Theater 1 Exhibit Hall
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-StrategicPlanning
  • 08: R and D Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: DIAmond
  • 14: InnovTheater
  • 15: Engage-Exchange
  • 16: Content Hubs
  • 17: Community Rounds
  • 18: ProfDevelopment
  • 19: Posters
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  • Biomarkers - Diagnostics
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