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17: Community Rounds [clear filter]
Monday, June 24
 

1:15pm

#130 RT: Round Table Discussion: Emerging Technologies in Clinical Research
Component Type: Session
Level: Basic

Round table discussion tied to session #107: Emerging Technologies in Clinical Research (Monday, June 24, 11:00AM - 12:00PM). Seating is limited. To include special guests from the session: Anthony Humphreys, Sonya Eremenco.

Chair

Keith W. Wenzel


Speakers
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Business Opeartions, Scientific Data Organization, Parexel
Mr. Wenzel holds the position of Senior Director within PAREXEL Informatics’ Solution Incubator, a team that brings innovation to clinical trials. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance... Read More →


Monday June 24, 2019 1:15pm - 2:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

9:30am

#223 RT: Round Table Discussion: Interpretation of New Pharmacovigilance Regulations: Key Insights
Component Type: Session
Level: Basic

Round table discussion tied to session #136: Interpretation of New Pharmacovigilance Regulations: Key Insights (Monday, June 24, 2:15-3:15PM). Seating is limited. To include special guests from the session: Ajay Singh, Jane Carroll.

Chair

Jeremy Jokinen, PhD, MS


Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.
Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. Jeremy has over 20 years... Read More →


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:30am

#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Session
Level: Basic

Round table discussion tied to session #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Elektra Papadopoulos, Telba Irony, Michelle Tarver.

Chair

Emuella Flood


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#254.1 RT: Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to the session #154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Meredith Smith, Marc Boutin, Herve Le Louet, Theresa Mullin, Kerry-Leeson-Beevers.

Chair

Judith Zander, MD


Speakers
avatar for Judith Zander

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#277 RT: Round Table Discussion: Clinical Research in Emerging Regions
Component Type: Session
Level: Basic

Round table discussion tied to session #156: Clinical Research in Emerging Regions (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Avik Pal, Asita de Silva.

Chair

Terry Katz, MS


Tuesday June 25, 2019 3:15pm - 4:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#276 RT: Round Table Discussion: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
Component Type: Session
Level: Basic

Round table discussion tied to session #202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration (Tuesday, June 25, 8:00-9:15AM). Seating is limited. To include special guests from the session: Songlin Xue, Michael Forstner, Jose Vega, Paul Chang.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Tuesday June 25, 2019 3:15pm - 4:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

9:30am

#323 RT: Round Table Discussion: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
Component Type: Session
Level: Basic

Round table discussion tied to session #219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? (Tuesday, June 25, 8:00-9:15AM). Seating is limited.

Chair

Emuella Flood


Wednesday June 26, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:30am

#322 RT: Round Table Discussion: Real World Data to Real World Evidence
Component Type: Session
Level: Basic

Join DIA Clinical Research Community for a round table discussion tied to session #218: Real World Data to Real World Evidence (Tuesday, June 25, 8:00-9:15AM). Seating is limited. To include special guests from the session: Andy Wilson, Sarah Short

Chair

Richard Zink, PhD


Wednesday June 26, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:45pm

#351 RT: Round Table Discussion: An Industry Collaboration on Pharmacovigilance Analytics
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #229: An Industry Collaboration on Pharmacovigilance Analytics (Tuesday, June 25, 10:30-11:30AM). Seating is limited.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Wednesday June 26, 2019 12:45pm - 1:45pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:45pm

#352 RT: Round Table Discussion: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
Component Type: Session
Level: Basic

Round table discussion tied to session #260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bob Paarlberg, Liz Roberts.

Chair

Nate Root, MSc


Speakers
avatar for Nate Root

Nate Root

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals
Nate is a disclosure and transparency professional, with over 6 years of experience in the environment, working for and with CROs, Big Pharma, Non-Profit, and Small Biotech. He is a member of the DIA Disclosure Community Core Team, PhUSE CTD initiatives, and creator of the West Coast... Read More →


Wednesday June 26, 2019 12:45pm - 1:45pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Component Type: Session
Level: Basic

Join DIA Clinical Safety and Pharmacovigilance Community for a round table discussion tied to the session #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions (Tuesday, June 25, 4:15-5:30PM). Seating is limited.

Chair

Judith Jones


Speakers
avatar for Judith Jones

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex
Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College... Read More →


Wednesday June 26, 2019 2:00pm - 3:00pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#375 RT: Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
Component Type: Session
Level: Basic

Join DIA Medical Writing Community for a round table discussion tied to session #307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? (Wednesday, June 26, 8:00-9:15AM). Seating is limited. To include special guests from the session: Mary Jean Matus, Lisa Iacono

Chair

Frank Hubbard, PhD, MS


Speakers
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my previous... Read More →


Wednesday June 26, 2019 2:00pm - 3:00pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#377 RT: Round Table Discussion: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bruce Donzanti.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Wednesday June 26, 2019 3:15pm - 4:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#376.1 RT: Round Table Discussion: Master Protocols: Applications in Oncology
Component Type: Session
Level: Basic

Join DIA Statistics Community for a round table discussion tied to the session #271: Master Protocols: Applications in Oncology (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Amy Xia

Chair

Freda W. Cooner, PhD


Speakers
FC

Freda Cooner

Director, Statistical Innovation, Amgen
Dr. Freda Cooner is currently a Director, statistical innovation in Amgen. She is leading the exploration of innovative design options for several oncology and non-oncology products, including master protocols and seamless trials. Before joining Amgen late last year, she was an associate... Read More →


Wednesday June 26, 2019 3:15pm - 4:15pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:30pm

#398 RT: Round Table Discussion: Digital Risk Minimization: The “Next Generation” Risk Management Tools
Component Type: Session
Level: Basic

Round table discussion tied to session #327: Digital Risk Minimization: The “Next Generation” Risk Management Tools (Wednesday, June 26, 10:30-11:45AM). Seating is limited. To include special guest from the session: Carmit Strauss, Simon Ingate, Meredith Smith.

Chair

Karen Ward, MS


Wednesday June 26, 2019 4:30pm - 5:30pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA