Basic Drug Development Training 201

A DGE Professional Workshop
Register Now View Agenda

June 18-19, 2019 | Anaheim, CA

Hyatt Regency Orange County

Course Overview

This course provides an overview of the FDA structure and organization, regulatory history and current framework within the US for development of drugs, biologics, medical devices, dietary supplements and medical foods.

The course focuses on phase appropriate considerations and decision-making, roles involved in each stage, regulatory strategy and evolution, and agency meetings. General topics will cover all phases of the development process (including manufacturing, nonclinical and clinical development, and necessary compliance for each), options for effective and streamlined regulatory strategies that will be commercially successful, and product launch and marketing.

Benefits of Attendance

  • Understand the historic evolution to the current framework for product development
  • Be able to identify the basic steps in pharmaceutical development
  • Gain hands-on experience of concepts and practical application of learnings
  • Learn key aspects and considerations in the regulatory processes
  • Understand key roles and responsibilities applicable to product development success

EVENT VENUE

Hyatt Regency Orange County

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11999 Harbor Blvd.
Garden Grove, CA 92840

(714) 750-1234
hilton.com

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

 

Agenda Coming Soon

REGISTRATION PRICING


COMPLETE 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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