Virtual Clinical Trials

in Drug Development

Register Now View Agenda

April 10-11, 2019 | Philadelphia, PA

Wyndham Philadelphia Historic District

Conference Overview

Patients no longer need to travel to a doctor’s office or a clinical research facility. Virtual clinical trials now bring treatments and care directly to them. This method of collecting data allows for more flexibility, making it easier for patients to participate in clinical trials.

Who should attend?

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies

Anyone involved in Clinical:

  • Development
  • Quality
  • Compliance
  • Research
  • Outsourcing
  • Monitoring
  • GCP
  • Patient Recruitment 
  • Site Selection

EVENT VENUE

Wyndham Philadelphia Historic District

Image

H400 Arch St.
Philadelphia, PA 19106
(215) 923-8660
Hotel Website

GET DIRECTIONS

Agenda Coming Soon

Tuesday, 11/13/18 - Day 1


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 INNOVATION

DON'T MISS IT

REGISTER NOW

FEATURING

Speakers & Faculty

Joe Hage

Joe Hage

Your Host
10x

Mike Sperduti

Mike Sperduti

CEO
Emerge Sales

Chris Sharp

Chris Sharp

President / CEO
SharpNET Solutions, Inc.

 

REGISTRATION PRICING


CONFERENCE ONLY

EARLY BIRD

Until 2/15/19

$1,696

STANDARD

After 2/15/19

$1,896

ON-SITE

Register at Event

$2,096

CONFERENCE + WORKSHOP

EARLY BIRD

Until 2/15/19

$2,396

STANDARD

After 2/15/19

$2,596

ON-SITE

Register at Event

$2,796

Register 2 Attendees, Get 1 Complimentary Registration*!

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

* Excludes Workshop Only

EVENT SPONSORS

SPONSOR THIS EVENT

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

Exhibit Booth Package Sponsorship

$9,500

SPONSOR

Advertising Package Sponsorship

$6,500

SPONSOR