Events

FUTURE TALKS & PRESENTATIONS



FDA's Emerging Policy on Clinical Decision Support Software and Mobile Medical Apps.  

4th Annual ComplianceOnline Medical Device Summit

June 7-8, 2018.  San Francisco.

For more info, click here


Drugs: Generics, Patents, and Exclusivity. 

Regulatory Affairs Certification (RAC) Review Course. San Diego Regulatory Affairs Network (SDRAN). 

June 14, 2018. Webinar.

For more info, click here


Transitioning to Non-Orphan Indications for Orphan Drugs.

Moderator, Panel Discussion, at 

Orphan Drugs & Rare Diseases -- 2018 Americas West Coast.

June 25-26, 2018.  San Diego, CA

For more info, click here

  

Regulation of Drug Manufacturing.

 Food & Drug Law Institute.

  Introduction to US Drug Law and Regulation. 

July 25, 2018. San Francisco.

For more info, click here


Combination Products, OTC Drugs, and Orphan Drugs. 

Regulatory Affairs Certification (RAC) Review Course. San Diego Regulatory Affairs Network (SDRAN). 

July 26, 2018. Webinar.

For more info, click here


Ensuring Compliance with FDA Requirements for Advertising
& Promotion of Drugs & Medical Devices.
 
Course Instructor, Two-Day Course. ComplianceOnline.  

July 26-27, 2018.  Chicago, IL.

For more info, click here


Critical Legal Issues Facing GMP Compliance.  

23rd Annual GMP By The Sea Conference.  

August 27-29, 2018.  Cambridge, MD.
For more info, click here

RECENT TALKS & PRESENTATIONS



FDA Inspections:  Handling the Consequences -- Understanding How Ugly It Can Get. 

MAGI's Clinical Research Conference

May 22, 2018.  Arlington, VA. 


What's In a Name?  FDA and Non-Proprietary Names for Biosimilars.  

11th Biosimilars & Follow-On Biologics 2018 Americas.  

Paradigm Global Events.

April 20, 2018.  McLean, Virginia.


Ensuring Compliance with FDA Requirements for Advertising
& Promotion of Drugs & Medical Devices.
 
Course Instructor, Two-Day Course. ComplianceOnline.  

March 22-23, 2018.  San Francisco, CA.  


Slides:
Part 1:  Basics

     Part 2:  Direct-to-Consumer Advertising

Part 3:  Scientific Dissemination  

     Part 4:  FDA Enforcement

Part 5:  Social Media & Internet  

Part 6:   First Amendment, Off-Label & False Claims; Guidance on Medical Product Communications Consistent with Labeling
Part 7:  FTC Regulation

     Part 8:  Handling at Company Level


The Application Integrity Policy (AIP):  A Little History.  
Webinar presentation sponsored by Food & Drug Law Institute (FDLI).

March 13, 2018


EU MDR & IVDR Implications for Manufacturers & Suppliers.
Moderator, Panel Discussion, at MD&M West, 

February 7, 2018, Anaheim, CA.  

[no slides; moderator]

News

Jan. 2013 -- SD Union Tribune Interview of Michael Swit (pdf)

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Jan. 2003 -- SD Union Tribune Profile of Michael Swit (pdf)

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