8:30 a.m - 9:45 a.m : |
Registration-Continental Breakfast-Networking |
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9:45 a.m : |
Opening Remarks/ Dr. Sharlin Introduction - Mr. Ram Balani, CEO/Founder FDASmart Inc. |
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Session 1: |
“Understanding How US FDA Reviewers Think and Work”
( or How to Eliminate Submission Review Cycles ) |
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10:00 a.m - 11:00 a.m : |
Dr. Joshua Sharlin – President, FDASmart Inc. |
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Description : |
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.
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Speaker Background : |
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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, |
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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. |
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| Session 2: |
“Clinical Trials Conducted Outside The United States: New US-FDA Regulations” |
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11:00 a.m - 12:00 p.m : |
Dr. Joshua Sharlin |
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Description : |
On this session, how and why FDA concluded that these new regulations will be applied retroactively will be discussed but more importantly 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) |
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12:00 p.m - 1:00 p.m : |
Lunch /Networking |
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Session 3:
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“Preparing for a Computer Systems Audit by US FDA” |
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1:00 p.m -2:00 p.m : |
Dr. Joshua Sharlin |
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Description : |
This session will discuss how “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…” |
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Session 4: |
"How US FDA Reviewers Are Trained"
( or How to Get Inside a US FDA Revewer’s Head ) |
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2:00 p.m - 3:00 p.m |
Dr. Joshua Sharlin |
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| Description : |
This session will discuss 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! |
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3:00 p.m - 3:30 p.m : |
Tea Break/Networking |
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Workshop Session |
US FDA Regulatory Strategy Workshop |
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3:30 p.m - 4:30 p.m : |
Dr. Joshua Sharlin
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Description : |
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.
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| Bonus Session: |
Open Forum Q&A –“What You Always Wanted To Ask The US FDA But Were Afraid To Ask” |
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4:30 p.m - 5:30 p.m : |
*** Audience Participation INVITED ! *** |
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Please share your know-how, experiences, stories or ask more questions in this session. |
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Post Event Networking |
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