Early Bird Rate of £ 349 Expires January 12th-2011
Registration price is £ 399 per person thereafter.

A Full Day US FDA Insider Secrets/ Seminar with Networking
at ICRI Global Research Campus- Milton Keynes, London
Wednesday, January 19, 2011

“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”

Is the US 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 get not-so-favorable impressions such as: Fear, Doubt, Apprehension ! 

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 a former US FDA reviewer  for a full-day, on-site seminar at ICRI Global Research Campus in Milton-Keynes, UK 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 January 19, 2011 at the ICRI Global Research Campus in Milton-Keynes, UK learn how to de-mystify the US FDA and turn it into your partner and not your adversary plus get up to speed with the LATEST regulatory compliance issues from former US FDA employee/expert !

Your presenter is:
Dr. Joshua Sharlin
  • Fdasmart Inc. President
  • 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
Location : ICRI Global Research Campus- Milton Keynes, UK
See www.fdasmart.com/usfdabootcamp/icriglobalmk.html for location details.
Date : January 19th, 2011  
Time : 8:30 am to 5:30 pm
Price : £ 349* Early Bird Registration ( £ 399* per person thereafter)
** All Credit Card Payments charged at US Dollar Currency.
Please call +1 516 515 9642 or email rbalani@fdasmart.com to make other payment arrangements.**

Includes FULL Day On-site Training/Seminar, Continental Breakfast, Lunch & Tea breaks
Seminar Agenda : See  Full Day Agenda here –>  www.fdasmart.com/usfdabootcamp/agenda.html
1 “ Understanding  How US FDA Reviewers Think and Work
2 “ Clinical Trials Conducted Outside the United States- Latest US FDA Regulations
3 “ Preparing for a Computer Systems Audit by US FDA”
4 “ How US FDA Reviewers Are Trained” (or How to Get Inside a US FDA Reviewer’s Head)
5 "US FDA Regulatory Strategy Workshop"
6  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 eliminate 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

“Preparing for a Computer Systems Audit by US FDA”

 By: Dr. Joshua Sharlin

“The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11…The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections…”

This quote is from a July 2010 addition to FDA’s web site regarding 21 CFR Part 11. It reflects the renewed agency interest in examining and enforcing compliance with the regulations for electronic records and electronic signatures.

FDA-regulated firms know information technology (IT) compliance is critical. Now, after a long dormancy, FDA is again focusing on computer systems processing important information about product safety or efficacy. If your IT systems fail to meet FDA regulations, it will put your submissions in jeopardy and expose your firm to negative inspection findings, warning letters, and even more stringent regulatory actions.

What You Will Learn:
  • Two perspectives of Part 11 audit: As a software developer and as a software user
  • Two strategies for dealing with auditors
  • The meaning of three key phrases in FDA's 2003 Part 11 scope and applications guidance: "interpreted narrowly", "FDA will not normally take regulatory action", and "enforce predicate rule requirements"
  • Eleven SOPs recommended by FDA
  • Five important compliance differences between software developed in-house, written by a CRO, or purchased from a vendor
  • How to interpret the phrase "Part 11 compliance"

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:

Workshop Session:

  US FDA Regulatory Strategy

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

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

Session 6:

Bonus Session:

End-of-Day Bonus Session – One on One Q & A with Dr. Sharlin

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 Presenter

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 and FDASmart US FDA training programs –please visit the FDASmart.com website section at: http://www.fdasmart.com/Mission_Statement.html


For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com
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