A full-day Bootcamp /On-site Seminar with Networking in Edison, New Jersey to be held Sept 30th-2010 on:

“US FDA Insider & Latest Regulatory Compliance Information You Must Know !”

-Featuring a unique insider session on “How US FDA Reviewers Work & Think”
& a bonus end-of-day open audience/forum Q&A on

“What you Always wanted to know about the US FDA but Were Afraid to Ask”
from 2 former US FDA employees/experts

Is the FDA a “black box” to you?
Do you know what reviewers are doing behind closed doors when they examine your submission?

Mention the “US FDA” to those in the industry - what comes to mind?

To most of us in the pharmaceutical, biotech and medical devices industry, chances are --- we see a not-so very pleasant picture such as: 

Can you anticipate a US FDA reviewer’s actions and reactions to your submission for product approval?

Do you know HOW  to improve the quality of your submissions to reduce US FDA review cycles  while  spending  less time and money?

Join two former US FDA reviewers  for a full-day, on-site in Edison, New Jersey seminar and get the answers to these questions and learn lots of insightful information about how to be more effective with FDA.

Chances are what you KNOW about what goes on INSIDE  the US FDA is  a mere “tip of the iceberg”.  Can you afford not to know WHAT OTHERS do & are using to their advantage ?

How many know, for instance, that US FDA drug reviewers are motivated to help companies improve the quality of their submission to facilitate review time and gain approval?.  But you must know how to deal and communicate with your US FDA reviewers effectively so they can in turn help you.

Believe it or not—the US FDA  wants to be your PARTNER and not an ADVERSARY !

The US FDA wants to speed up the regulatory submission process as much as possible without compromising the quality of information or regulatory requirements. The agency wants to make good on its mission by working as expediently as possible with YOU!  You, however need to KNOW HOW THEY WORK INTERNALLY and learn how to USE this insider KNOW-HOW to YOUR ADVANTAGE for regulatory submissions or other business with the US FDA!

On September 30th at Pines Manor, Edison-New Jersey –learn how to de-mystify the US FDA and turn it into your partner and not your advesary plus get up to speed with the LATEST regulatory compliance issues from 2 former US FDA employees/experts !

Your presenters are:
Dr. Joshua Sharlin
  • Former US FDA Drug Reviewer, Washington, DC
  • World class trainer. Has taught over 40,000 students from over 1,000 FDA regulated companies on mission critical regulatory and technical topics.
  • Has delivered US FDA regulatory compliance training to  India’s leading CRA training institute
  • Master consultant to global pharmaceutical , biotech, biologics and medical device
Dr. Stanley Edlavitch
  • Former Head – First Epidemiology Branch at the US FDA, Washington, DC
  • Founder and First Executive Director of ISPE- (International Society for Pharmacoepidemiology)
  • Professor- UMKC and  Global Clinical Trials Exper
Location : Pines  Manor, Edison-New Jersey
Date : September  30th,  2010  
Price : $ 399 Early Bird Registration / $ 459 thereafter
Seminar Agenda : See  Full Day Agenda here –>  www.fdasmart.com/usfdabootcamp
1 “ Understanding  How US FDA Reviewers Think and Work” (or How to Reduce Submission Review Cycles)
2 “ Clinical Trials Conducted Outside the United States- Latest US FDA Regulations
3 Adverse Event Reporting & Pharmacovigilance –  Mandatory US and Foreign Trials Requirements
4 “ How US FDA Reviewers Are Trained” (or How to Get Inside a US FDA Reviewer’s Head)
5 “ Case Study: NIH Sponsored Foreign Clinical Trial in India”
6 "US FDA Regulatory Strategy Workshop": Dr Joshua Sharlin
7  End-of-Day Bonus Open forum: “What You Always Wanted to Ask the US FDA But Were Afraid to Ask”

Session 1  
“Understanding how US FDA Reviewers Think and Work”

(How to reduce submission reviewer cycles)

By: Dr. Joshua Sharlin

US-FDA Drug Submissions: You've finally completed your submission to the US-FDA and are ready to send it in. What are the FDA reviewers going to think? Are you sending in a submission that will delay, or worse, deny your product's approval?

This seminar is designed to give you the essentials for preparing an outstanding submission. It will describe general principles of how to improve submissions and applies to drugs including generics, devices and biologics. In addition, our presenter will summarize the results of an FDA sponsored study that he worked on, that identified distinguishing characteristics of NDAs and BLAs approved with no review cycles.

What You Will Learn:

  • The single most important action a company can perform to reduce approval time, as recommended by a FDA sponsored study
  • How US FDA reviewers do their job
  • Factors that influence how  US FDA reviewers think
  • Why meeting just the requirements in the Code of Federal Regulations and guidance documents is insufficient
  • How to anticipate reviewer's actions and reactions
  • An understanding of how to present information so FDA reviewers can quickly agree with your company's results and conclusions

Session 2

“Clinical Trials Conducted Outside the United States: New US-FDA Regulations”

By: Dr. Joshua Sharlin

On April 28, 2008 US-FDA announced new regulations about the acceptability of data from clinical studies performed outside the United States. These new regulations apply to studies not conducted under an IND but intended for an IND NDA (drug), BLA (biologic) or ANDA (generic drug) submissions.

FDA will apply these new regulations to non-IND clinical trials even if today they are on-going or even completed as long as they are part of an IND NDA, ANDA or BLA application made after October 25, 2008.

Failure to comply with these new regulations could result in FDA's rejection of your data and put your product's approval at risk. Make sure you're familiar with these brand-new and very different new regulations.

What You Will Learn:

  • How and why FDA concluded that these new regulations will be applied retroactively
  • Why following just the ICH E6 and ICH E3 guidance will not meet all requirements of these new regulations. (ICH-International Conference on Harmonization; E6-Good Clinical Practice, E3-Structure and Content of Clinical Study Reports)
  • Regulations governing FDA's onsite inspection of clinical studies conducted outside the U.S.
  • How to get a waiver for these requirements from FDA
  • Impact of these new regulations on compliance with local laws

Session 3

“Adverse Event Reporting & Pharmacovigilance – Mandatory US & Foreign Clinical  Trial Requirements”

 By: Dr.  Stanley Edlavitch

Are your reporting efforts ready to withstand FDA's intense focus on product safety? Complying with safety reporting regulations has become a complex process that requires the coordination and cooperation of many people – and the key to documenting that you have made this process run smoothly is the quality of the Standard Operating Procedures (SOPs) you develop.
This session will review the reporting requirements for foreign clinical trials conducted outside of the US.

What You Will Learn:
  • US reporting requirements for serious and non-serious events
  • 15-day reports
  • What needs to be reported to the foreign regulatory authority?
  • What response can you expect from the US FDA?
  • What response might you expect from the foreign authority?
  • Key differences in US and some  major foreign agency requirements

Session 4

“How US FDA Reviewers are Trained”

 By: Dr. Joshua Sharlin

How does a new FDA employee become a reviewer? Knowing how FDA trains new hires to be reviewers is important in understanding how a diverse group of scientists can consistently approach and view drug, device, and biologic submissions -- including yours!

What You Will Learn:

  • Nine protocol elements reviewers are taught to evaluate
  • Detailed templates reviewers must follow when examining submissions and writing reviews
  • Four tasks that explain how reviewers study a submission
  • Types of information used by reviewers to understand internal FDA practices and procedures for handling    submission information and regulatory issues, including:
  • MaPPs (Manual of Policies and Procedures) used by the Center for Drugs
  • SOPPs (Standard Operating Procedures and Policies) used by the Center for Biologics
  • Blue Book Memos used by the Center for Devices
  • Specific instructions FDA staff must follow when conducting an inspection
  • Software tools reviewers use to examine submission information and what you should know about them

Session 5

NIH Sponsored Foreign Clinical Trial in India”

  By: Dr.  Stanley Edlavitch

This session will review the reporting requirements for foreign clinical trials conducted outside of the US.

The number of studies conducted in India by pharmaceutical companies to support US submissions has increased dramatically in recent years.    There are a number of challenges that the sponsor faces when conducting randomized clinical trials in India.  This session will review the experience of one team that successfully conducted a 4-year clinical trial, enrolling 1600 patients in rural India.

What You Will Learn:
  • Unique aspects of study approval at local and governmental level in India
  • What are local concepts of informed consent?
  • How do you avoid incentives for study personnel to “cheat?”
  • Importing study drugs – incentives and barriers
  • Safety reporting – US and Indian requirements
  • Communications, communications, communications

Workshop Session:

US FDA Regulatory Strategy Workshop

There’s always more than one path to your regulatory submission approval. But which choice is best? Which option will get your product to market the fastest?

This workshop will examine a series of real-life problems and you’ll work in groups to develop solutions.

Topics to be included in the workshop :
 -Wording of a claim

- How to handle regulatory deficiencies
- Characteristics of convincing evidence for safety and efficacy.

Bonus Session:

End-of-Day Bonus Session – One on One Q & A with Presenters— former US FDA Drug Reviewers-INSIDERS !

What You Always Wanted to Know about the US FDA but were afraid To Ask!
  • Join our expert for 30 minutes of non-stop Q & A with YOU…the audience
  • Your chance to fire away at those nagging question regarding what, how, where and when – anything you wish to ASK regarding the US FDA and your submission issues!

Who Should Attend:

  • Management/executives from the pharmaceutical, biotech, biologics or medical devices industry sector who wish to LEARN how to de-mystify the US FDA to Speed up Regulatory Submission Approval
  • US FDA regulatory  compliance officers who need to know MUST-HAVE and ground-breaking US FDA guidance and mandates that affect your companies new drug approval period
  • Foreign Ministry and state government officials who need the latest know-how and intelligence for  decision making affecting US- foreign regions pharma trade
  • Senior ranks from vendor companies and Life sciences fund directors/managers who wish to learn HOW to TRANSLATE INSIDER & NEW on the horizon pharma regulatory knowledge into competitive business advantage

About Our Presenters 

Dr. Joshua Sharlin

Joshua Sharlin has a Ph.D. in physiology and worked at the US-FDA as a statistical reviewer and as a reviewer that examined drug safety and efficiency. As FDASmart’s expert consultant/ trainer, he has practical hands-on experience in many aspects of drug, biologic and medical device development including; regulatory affairs, protocol development, design and execution of studies, data collection, data management, data reporting, statistical analysis, software programming and validation, writing SOPs and protocols, and finally FDA compliance.

He regularly audits CROs and product sponsors for GCP compliance and is an expert in software development and information technology compliance. Before joining the FDA, he taught programming for SAS Institute and was Director of Hotel Customer Information Systems for Marriott hotels.

Dr. Sharlin has developed 36 classes on FDA-related topics such as compliance, validation, GCP auditing, SAS programming, product safety reporting, electronic submissions and writing SOPs. Over 35,000 people have attended his presentations. He serves as company  President at FDASmart Inc. For more on Dr. Sharlin –please visit the FDASmart.com website section at: http://www.fdasmart.com/Mission_Statement.html


Dr.  Stanley Edlavitch

Stan Edlavitch, PhD, MA currently splits his time between academic and consulting/industry appointments. 

He is Professor of Epidemiology in the Department of Psychiatry at the University of Missouri School of Medicine and Adjunct Professor of Epidemiology in the Departments of Maternal and Child Health at UMKC, in the Department of Infectious Disease at Kansas University School of Medicine, and at Tianjin Medical College, Tianjin, China. He is also President of Global Epidemiology Services.  He currently consults and conducts research in several European Countries, India, and China. 

Professor Edlavitch is the founder and first executive director of the International Society for Pharmacoepidemiology (ISPE) and has previously held senior positions directing epidemiology, bioinformatics and health economics programs at the US FDA, in the pharmaceutical industry, in academia and in managed care.

He has a PhD in epidemiology from the University of California, Berkeley and a Masters in Mathematical Statistics from the University of Missouri, Columbia. He serves as co-chair of the Health Planning Committee for the Health Commission in Kansas City, Missouri, is a member of the Missouri Governors Advisory Committee on Suicide Prevention and is Secretary/Treasurer of the Steering Committee for the Kansas State Suicide Prevention Committee. He is also Chairman of the Board of the Kansas City Suicide Awareness and Prevention Program. 

Past Event Full e-book are available for purchase 
For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com