Phase-Appropriate Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)  Boot Camp

Register Now View Agenda

June 12-13, 2019 | Philadelphia, PA

Venue TBD

Course Overview

This boot camp will explore current regulations for advancing drugs from research to early clinical development. Come outline the practical applications of phase 1 manufacturing strategies to meet FDA requirements. 

Don’t miss out on understanding the advanced concepts for GMP and QSR!  

Who Will Benefit

The following professionals will benefit from this training: 

  • Regulatory Affairs Departments
  • Quality Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Clinical Operations Professionals

EVENT VENUE

Wyndham Philadelphia Historic District

Image

H400 Arch St.
Philadelphia, PA 19106
(215) 923-8660
phillydowntownhotel.com

GET DIRECTIONS

Agenda Coming Soon

DAY 1


Tuesday, 11/13/2018


Session One

FDA Scope & Organization

Session Two

History of US Regulation

  • Key changes that have occurred and the interesting historical reasons

Basic Development & Regulatory Framework for Various application and product types, including study types and requirements, and available pathways

  • Drugs – IND/NDA/ANDA/OTC
  • Devices – IDE/510(k)/PMA
  • Biologics – IND/BLA/Biosimilars
  • Dietary Supplements
  • Medical Foods

Session Three

Basic Framework

  • Orphan drugs
  • Breakthrough therapy designation
  • Parallel review
  • Fast track
  • Priority review
  • Exclusivity
  • RX to OTC switch
  • Pediatric development

DAY 2


Wednesday, 11/14/2018


Session Four

Meetings with the FDA

  • Available meetings
  • Requirements for scheduling
  • Planning & conducting

Session Five

Submission Structure – CTD/eCTD

  • Commercialization
  • Planning with the label in mind
  • Negotiating the labeling
  • Advertising & promotion
  • Ongoing regulatory commitments

THREE DAYS OF EDUCATION AND FUN

DON'T MISS IT

REGISTER NOW

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

 

REGISTRATION PRICING


COMPLETE WORKSHOP

TWO-DAY WORKSHOP

$1,296

REGISTER NOW

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

SPONSOR

Advertising Package Sponsorship

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