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03: Data-Data Standards [clear filter]
Tuesday, June 25
 

2:00pm

#274 EE: Pharma Powered by the Digital
Component Type: Workshop
Level: Basic

Pharma companies are experimenting with a range of digital health initiatives. This workshop will help the audience appreciate the complexity of implementing digital solutions through mock cases and interactive discussions about key challenges.

Learning Objectives

Identify opportunities and challenges associated with digital health technologies; Discuss approaches and strategies to more effectively engage in digital healthcare initiatives; Apply best practices to future digital health implementation.

Chair

Fabian D'Souza, MD, MBA


Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc.
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

10:00am

#326 CH: 2020 and Beyond, Data Capture Across Systems, Functions, and Modalities
Component Type: Workshop
Level: Advanced

This workshop will lead an interactive discussion related to clinical trials of the future. How will pharmaceutical companies interact with sites and patients? How do we better connect trial conduct and outcomes to our data consumers?

Learning Objectives

Discuss organization strategy; Recognize data modalities and their impact on the clinical trial space; Describe clinical trials of the future with an emphasis on data and site management.

Chair

Muzafar Mirza

Speaker

Facilitator
John Manlay, MS



Speakers
MM

Muzafar Mirza

Director, Program Lead, Pfizer Inc
Muzafar (Muz) Mirza is currently a Program Lead for the Hematology Portfolio in the Oncology Therapeutic Area that is part of the Data Monitoring &Management (DMM) group at Pfizer. As well as managing aspects of the Oncology portfolio, Muz is working on addressing challenges related... Read More →
JM

John Manlay

Director Clinical Data Management, Pfizer Inc


Wednesday June 26, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra



Speakers
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Stephen Corson

Stephen Corson

Senior Statistician, Phastar
I am a Senior Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#409: Case Studies From FDA and MHRA: Good Clinical Practices
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-723-L04-P; CME 1.25; IACET 1.25; RN 1.25

If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.

Learning Objectives

Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.

Chair

Gail Francis

Speaker

MHRA Perspective
Stephen Vinter

FDA Perspective
Jean M. Mulinde, MD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA