Basic Drug Development Training 101

A DGE Professional Workshop
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March 4-5, 2019 | Philadelphia, PA

Sheraton Philadelphia University City Hotel

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

Sheraton Philadelphia University City Hotel

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3549 Chestnut Street
Philadelphia, PA 19104

(215) 387-8000
marriott.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.

Monday, March 4th, 2019 | Day 1

 

8:00 AM - 8:30 AM

Registration and Continental Breakfast

8:30 AM - 8:45 AM

Opening Remarks

Peggy J. Berry - President & CEO
Synergy Consulting

8:45 AM - 10:45 AM

FDA Scope & Organization

The scope of the FDA’s regulatory authority is very broad. With less than 8000 employees, FDA regulates approximately 60% of the GDP in the US, including food, drugs, cosmetics, and veterinary products. Learn the full extent and impact of their activities on your life personally and professionally, and how they organize to do so much with so few.

  • FDA’s mission in its regulation
  • FDA’s top priorities for regulation
  • How they organize to achieve their mission & meet their priorities

10:45 AM - 11:15 AM

Networking Break

11:15 AM - 12:15 PM

History of US Regulation

You may feel like there are massive requirements to get a product developed & approved. A system so complex and intricate that you may never learn to success fully navigate it. However, while there are complexities, it is navigable and understandable. This session will explore the interesting historical events leading to our current regulatory framework and the currently available pathways to drug approval.

  • Learn the submissions required for study and approval for your drug, device, biologic, medical food, or dietary supplement
  • Learn the format required for your submissions in an effort to give patients
  • Overview of devices regulation for IDE/510(k)/PMA
  • Address biologics and biosimilars including IND/BLA
  • Touch on dietary supplements and medical foods

12:15 PM - 1:15 PM

Networking Lunch

1:15 PM - 2:15 PM

History of US Regulation (Continued)

2:15 PM - 3:15 PM

Special Programs to Consider

To add the complexity of possibilities for development of drugs, there are several special programs available that you may want to consider for your product. These special programs can provide any various advantages for your product, such as faster time to market, fewer studies, more FDA interaction and guidance, and cast-savings.

This session will go in depth on the advantages & qualifying requirements for the following:

  • Orphan drugs
  • Breakthrough therapy designation
  • Parallel review
  • Fast Track
  • Exclusivity
  • RX to OTC switch
  • Pediatric development
  • Patient’s Right to Try
  • Appreciate the history of how we got to where we are today

1. Practical Application Exercise: Map out considerations for your product and its requirements

2. Practical App Ex.: Test your knowledge on the requirements of special programs to see if your products fits

3. Discussion: What creative strategies can you employ to advance your products

3:15 PM - 3:30 PM

Networking Lunch

3:30 PM - 4:30 PM

Special Programs to Consider (Continued)


Tuesday, March 5th, 2019 | Day 2

 

8:00 AM - 9:00 AM

Registration and Continental Breakfast

9:00 AM - 9:15 AM

Recap of Day 1 Sessions 

Peggy J. Berry - President & CEO
Synergy Consulting

9:15 AM - 10:45 AM

Meetings with the FDA

To assist in navigating the intricate web of regulations and requirements, the FDA offer several key points of interaction during the development process.

  • Learn what meetings are possible for your products during your development life cycle and what you should aim to get out of them
  • Learn how to take advantage of these meetings from scheduling to planning and conducting the meeting to gain full understanding and actionable output
  • Review case studies of successful negotiation and communication during meetings
  • See lessons learned from less successful meetings and how to manage that during the meeting and recover after the meeting

10:45 AM - 11:15 AM

Networking Break

11:15 AM - 1:15 PM

Beginning with the End Target in Mind

The largest goal of every development program is to help patients and enhance their lives. However, that cannot be accomplished philanthropically, so you have to consider what you need to have at the end of the day in order to make money. So how do you ensure that you will hit the target!

  • What is a Target Product Profile (TPP) and how do you create it
  • One step beyond the TPP – the claims needed to resonate with customers
  • Materializing the development plan from your targets
  • Practical Application Exercise: Turn a TPP into a Development Program

THREE DAYS OF EDUCATION AND FUN

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COMPLETE WORKSHOP

TWO-DAY WORKSHOP

$1,296

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Register 2 Attendees, Get 1 Complimentary Registration!

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

EVENT SPONSORS

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

Exhibit Booth Package Sponsorship

$9,500

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