Medical Affairs Compliance | DarshanTalks

In this episode of DarshanTalks Podcast where host Darshan Kulkarni Pharm.D, MS, Esq. welcomes guest Michael A. Swit, Esq. to discuss Medical Affairs Compliance. Michael A. Swit is a long-time FDA regulatory Attorney and Chief Regulatory Counsel at Varian Medical Systems. He has taught and written on an array of subjects relating to FDA regulation and related commercial activities, including directing courses on FDA regulation of drug/device advertising and on generic drug approvals. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit has spoken frequently at conferences sponsored by such organizations as RAPS, FDLI, and DIA. Swit is a highly experienced food & drug law attorney who has addressed critical FDA legal issues since 1984. His vast experience includes serving as general counsel and secretary of Par Pharmaceutical, a prominent generic drug company, and, thus, he brings a commercial perspective to his work. His private practice has included stints in the FDA Law Practice Groups in the San Diego offices of both Duane Morris and Heller Ehrman, and at McKenna & Cuneo (now Dentons), in the firm's D.C. and San Diego offices. He also served for seven years as Vice President at The Weinberg Group, a premier FDA regulatory consulting firm, and as the CEO of FDAnews.com, a premier publisher of FDA newsletters and other information products.

In the initial part of the podcast, he described how to do the Varian Company functions and its role in medical affairs. At Varian, he spearheads the resolution of all legal issues impacting the regulatory, quality, and clinical challenges of the world's leading developer of radiation treatment technologies used to treat cancer and other conditions, including overseeing the firm's promotional review process. The company's aim is 'creating a world without the fear of cancer'. He mentioned every company makes mistakes or sometimes customers think that the company has done something wrong and every sphere will have a problem that is unavoidable but how to respond and the key element to tackle those circumstances that determines everything. He works in the compliance department resolving disputes and problems. The mid-segment was about the work processes and balance, then he was asked about the SOPs in medical affairs i.e. standard operating procedures for clinical practice, he had prime approaches for the same - policies, SOPs, granular work construction, and it ought to be automation. He also mentioned mnemonic words that are important in this sphere. The conversation also included The Chicago Tylenol scandal ( these were a series of poisoning deaths resulting from drug tampering in the Chicago metropolitan area in 1982) concerning crisis management and how one can do a right recall. Lastly, they touched upon the influencer marketing aspect.

Connect with Michael A. Swit:
https://www.linkedin.com/in/michaelswit/

Connect with us:
Website: http://www.darshantalks.com
Law Firm: http://www.kulkarnilawfirm.com
Twitter: https://twitter.com/darshantalks

----
Disclaimers:
1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.
2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.
3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.
4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice.
5. This does not create an attorney-client relationship.
Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of DarshanTalks Podcast where host Darshan Kulkarni Pharm.D, MS, Esq. welcomes guest Michael A. Swit, Esq. to discuss Medical Affairs Compliance. Michael A. Swit is a long-time FDA regulatory Attorney and Chief Regulatory Counsel at Varian Medical Systems. He has taught and written on an array of subjects relating to FDA regulation and related commercial activities, including directing courses on FDA regulation of drug/device advertising and on generic drug approvals. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit has spoken frequently at conferences sponsored by such organizations as RAPS, FDLI, and DIA. Swit is a highly experienced food & drug law attorney who has addressed critical FDA legal issues since 1984. His vast experience includes serving as general counsel and secretary of Par Pharmaceutical, a prominent generic drug company, and, thus, he brings a commercial perspective to his work. His private practice has included stints in the FDA Law Practice Groups in the San Diego offices of both Duane Morris and Heller Ehrman, and at McKenna & Cuneo (now Dentons), in the firm's D.C. and San Diego offices. He also served for seven years as Vice President at The Weinberg Group, a premier FDA regulatory consulting firm, and as the CEO of FDAnews.com, a premier publisher of FDA newsletters and other information products.

In the initial part of the podcast, he described how to do the Varian Company functions and its role in medical affairs. At Varian, he spearheads the resolution of all legal issues impacting the regulatory, quality, and clinical challenges of the world's leading developer of radiation treatment technologies used to treat cancer and other conditions, including overseeing the firm's promotional review process. The company's aim is 'creating a world without the fear of cancer'. He mentioned every company makes mistakes or sometimes customers think that the company has done something wrong and every sphere will have a problem that is unavoidable but how to respond and the key element to tackle those circumstances that determines everything. He works in the compliance department resolving disputes and problems. The mid-segment was about the work processes and balance, then he was asked about the SOPs in medical affairs i.e. standard operating procedures for clinical practice, he had prime approaches for the same - policies, SOPs, granular work construction, and it ought to be automation. He also mentioned mnemonic words that are important in this sphere. The conversation also included The Chicago Tylenol scandal ( these were a series of poisoning deaths resulting from drug tampering in the Chicago metropolitan area in 1982) concerning crisis management and how one can do a right recall. Lastly, they touched upon the influencer marketing aspect.

Connect with Michael A. Swit:

https://www.linkedin.com/in/michaelswit/

Connect with us:

Website: http://www.darshantalks.com

Law Firm: http://www.kulkarnilawfirm.com

Twitter: https://twitter.com/darshantalks

----

Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice.

5. This does not create an attorney-client relationship.

Learn more about your ad choices. Visit megaphone.fm/adchoices