Dissecting & Interpreting FDA Regulations & Guidelines Boot Camp 

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February 20-21, 2019 | Philadelphia, PA

Sheraton Philadelphia University City Hotel

Course Overview

FDA laws and regulations form the foundation of the system and requirements for development of drugs, biologics, and devices, gaining approval and ongoing responsibilities after marketing. It is not always easy to interpret or apply these requirements to specific projects. To assist with this, the FDA has published hundreds of guidance documents to share their current expectations and best practices. This mass of information can be time-consuming to wade through, form strategic plans, and practical implementation tactics. This workshop will explain the overall structure of FDA's regulatory system and how to interpret and best use the plethora of information available to support your development program. Hands on activities for practical application will be used to stimulate discussions and reinforce learnings.

Benefits of Attendance

FDA laws, regulations, and guidelines are complex and can be challenging to interpret and know how to apply to your development program.

In this boot camp, we will:

  • Review the scope and relationship of FDA laws, regulations, and guidance documents.
  • Explain how to interpret the legal requirements for developing drugs, Biologics, and devices.
  • Learn to dissect and apply guidance documents.
  • Discuss multiple interpretations and application of guidance documents.
  • Examine acceptable deviation from guidance documents and discussing them with the FDA.
  • Resolving conflicts in interpretation and application of guidance documents to your programs.

EVENT VENUE

Sheraton Philadelphia University City Hotel

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3549 Chestnut Street
Philadelphia, PA 19104
215-387-8000
Hotel Website

SPECIAL EVENT RATE
Click to Book Now

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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.

Wednesday, February 20th, 2019 | Day 1

 

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 10:00 AM

Overview of FDA’s Regulatory Structure of Laws, Regulations, Guidelines, and Other Useful Information Available

10:00 AM - 10:30 AM

Different Options for Implementation of this Available Information When Applying to Different Products

10:30 AM - 10:45 AM

Networking Break

10:45 AM - 11:15 AM

Overview of Major Differences in Foundational Requirements for Drugs, Biologics, & Devices

11:15 AM - 12:15 PM

Practical Application Activity

12:15 PM - 1:15 PM

Networking Lunch

1:15 PM - 2:15 PM

Navigation of the FDA Website to Find Information

2:15 PM - 3:15 PM

Deep Dive into the FD&C Act and the PHS Act

3:15 PM - 3:30 PM

Networking Break

3:30 PM - 4:30 PM

Deep Dive into IND Regulations for Drugs & Biologics, Including Importance of the Preamble

4:30 PM - 5:15 PM

Deep Dive into IDE Regulations for Devices


Thursday, February 21st, 2019 | Day 2

 

8:00 AM - 8:30 AM

Continental Breakfast

8:30 AM - 9:00 AM

Review of Day 1 / Q&A

9:00 AM - 10:00 AM

Deep Dive into Marketing Applications for Drugs & Biologics

10:00 AM - 10:30 AM

Understanding of the Legal Application Forms Through Practical Application

10:30 AM - 11:00 AM

Networking Break

11:00 AM - 12:30 PM

Practical Application into Select Guidance Documents to Understand Structure and Interpretation Elements

12:30 PM - 1:00 PM

Case Study Activities for Drugs & Biologics – Designing the Right Strategy

1:00 PM - 1:30 PM

Using Supplemental Information to Advance Better Strategies and Potential Risks

  • FDA Meetings
  • Inspection Warning Letters
  • FDA Reviews
  • Federal Register
  • Staying Informed

THREE DAYS OF EDUCATION AND FUN

DON'T MISS IT

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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

 

REGISTRATION PRICING


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

$9,500

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Advertising Package Sponsorship

$6,500

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