Latest Regulatory Developments in GCPs Workshop

A DGE Professional Event
Register Now View Agenda

April 10-11, 2019 | Philadelphia, PA

Wyndham Philadelphia Historic District

Course Overview

All sponsors, sites, and CRO’s involved in the drug, biologic and device Clinical Research and Development process must follow Good Clinical Practices (GCPs). Therefore, it is critical to remain up to date on all relevant GCPs related to the program of the clinical development and the geographical location of the clinical site and submission destination (s). Since many companies conduct clinical trials and make submissions World-Wide, remaining aware of new and changing GCPs and the appropriate application to your programs can be a daunting and task.

This workshop will provide an overview of the latest developments in GCPs during 2018 and what to expect in 2019, including those from Regulatory Agencies and Industry Consortiums who recommend processes and standards.

The most critical and most impactful documents will be discussed extensively regarding implications to various types of programs, companies, and overall practical application.

EVENT VENUE

Wyndham Philadelphia Historic District

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H400 Arch St.
Philadelphia, PA 19106

(215) 923-8660
Hotel Website

Special Event Rate
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Instructor

Peggy J. Berry

President & CEO Synergy Consulting

Peggy is the Executive Regulatory Lead at 3D Communications and President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of regulatory strategy and overall drug development.

THREE DAYS OF EDUCATION AND FUN

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FEATURING

Speakers & Faculty

Lance Black MD

Lance Black MD

Med Device Innovation Lead
Texas Medical Center

Jon Speer

Jon Speer

Founder & VP
Greenlight.guru

Jason Spencer

Jason Spencer

Market Dev
Henkel

MB Privitera

MB Privitera

Principal
HS Design

Joe Hage

Joe Hage

Your Host
10x

Sarah Wright

Sarah Wright

Director
ResMed

Michael Drues

Michael Drues

Regulatory Strategy Consultant
Vascular Sciences

Tor Alden

Tor Alden

Principal
HS Design

Anne Leijsen

Anne Leijsen

Head of Medical Writing
Factory CRO

Bob Marshall

Bob Marshall

Chief Editor
Med Device Online

Doug Fankell

Doug Fankell

Engineer
Structural Integrity Associates

Hitesh Mehta

Hitesh Mehta

Engineer
Integer (formerly Greatbatch)

Bobby Boyer

Bobby Boyer

Director, Product Dev.
HS Design

Srihari Yamanoor

Srihari Yamanoor

R&D Engineer III
Stellartech Research

Christine Zomorodian

Christine Zomorodian

Principal Consultant
Gish Consulting

Arlen Ward

Arlen Ward

Modeling & Simulation Principal
System Insight Engineering

Scott Phillips

Scott Phillips

President
StarFish Medical

Martin Coe

Martin Coe

Systems Engineering Professional
Medical Devices, CSEP

Walt Maclay

Walt Maclay

President
Voler Systems

 

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Wednesday, April 10th, 2019 | Day 1

 

7:30 AM - 8:30 AM

Registration and Breakfast

8:30 AM - 9:00 AM

Introduction

9:00 PM - 12:30 PM

Risk-based monitoring (ICH E6 R2)

  • Overview of risk-based monitoring 
  • Roles & Responsibilities in risk-based monitoring
  • Planning approaches to risk-based monitoring
  • Developing a monitoring plan
  • Developing a risk management plan for clinical studies
  • Documenting oversight and monitoring of clinical studies

Activity: Sample Study Risk Assessment
Discussion: Challenges to implementation of E6R2
Review: Example Monitoring Plan

10:30 AM - 11:00 AM

Networking Break

12:30 PM - 1:30 PM

Networking Lunch

1:30 PM - 2:30 PM

Pregnant Woman in Clinical Trials

  • Overview of Guidelines and Regulations that apply
  • Discussion: When is the appropriate time to include Pregnant women in research

2:30 PM - 3:30 PM

Clinicaltrials.gov

  • FDA’s recent attention toward entries and timing on clinicaltrials.gov
  • Review of the clarified requirements

3:30 PM - 3:45 PM

Networking Break

3:45 PM - 5:00 PM

Electronic Health Records and the EDC system

  • Overview of FDA guidance to sites on electronic health records
  • Ways to ensure effective integration from EHR to the study EDC system
  • Discussion: Challenges of integrating effectively

Thursday, April 11th, 2019 | Day 2

 

7:30 AM - 8:30 AM

Breakfast

8:30 AM - 9:30 AM

Informed Consent

  • Proposal to allow waiver or alteration of informed consent
  • eConsents

9:30 AM - 10:00 AM

Mobile Technologies in Clinical Trials

  • Effectively managing and controlling

10:00 AM - 10:15 AM

Networking Break

10:15 AM - 12:30 PM

EU

  • Clinical Trials Directive
  • Trial Master Files Guideline
  • eSource Direct Data Capture Guideline

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REGISTRATION PRICING


WORKSHOP

TWO-DAY WORKSHOP

$1,296

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Interested in sending groups of 7 or more? Contact us directly for pricing.

EVENT SPONSORS

SPONSOR THIS EVENT

Contact Eric Morrin at (561) 221.6204
or email emorrin@dgeve.com

Exhibit Booth Package Sponsorship

$9,500

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Advertising Package Sponsorship

$6,500

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