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01: ClinSafety-PV [clear filter]
Monday, June 24
 

12:15pm

#125 EE: ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)
Component Type: Workshop
Level: Intermediate

FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this session the implementation plan for E2B(R2) IND safety reporting will be discussed in use case-based scenarios.

Learning Objectives

Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS); Describe several E2B R2 data elements, including regional elements that are key for premarket safety reporting.

Chair

Meredith K. Chuk, MD, MHS

Speaker

Facilitator
Suranjan De



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Monday June 24, 2019 12:15pm - 1:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:00pm

#126 CH: Separating the Hype from Reality in Pharmacovigilance Automation
Component Type: Workshop
Level: Intermediate

This interactive session will synthesize the PV automation journey and share lessons learned through case studies of solutions implemented at pharma companies. It will cover the technical, process, governance, and compliance challenges encountered.

Learning Objectives

Develop an end-to-end perspective on implementing pharmacovigilance (PV) process automation and the benefits being achieved in operation; Describe preparing the business case and roadmap and how to manage expectations; Identify technology choices, compliance issues, and change management considerations.

Chair

Jill Notte

Speaker

Facilitator
Harpreet Singh Kanwar



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 →
avatar for Harpreet Kanwar

Harpreet Kanwar

CTO Life Sciences, Cognizant
Harpreet Kanwar has more than 25 years’ experience in information technology and leads digital transformation programs for global pharma companies. As Chief Technology Officer, he is responsible for driving emerging technology adoption, delivery transformation, technology and architecture... Read More →


Monday June 24, 2019 1:00pm - 1:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

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
 

8:30am

#402 CH: Manage Risks and Enhance Engagement Through Digital Approaches
Component Type: Workshop
Level: Intermediate

Even now, most risk minimization programs are paper based, though digital communication is used in all aspects of our lives. Digital channels provide a more engaging and effective educational experience through dynamic presentation and interactivity

Learning Objectives

Describe where digital approaches can be used to achieve better engagement in risk management outreach; Discuss what lessons can be learned from current projects through case studies; Determine top priority changes in people, process or tech to enable a move to digital in their own organizations.

Chair

Mark Perrott, PhD


Speakers
avatar for Mark Perrott

Mark Perrott

Head of Development Consulting, Huron Life Sciences
Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →


Thursday June 27, 2019 8:30am - 9:00am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA