In 2013, Congress enacted the Drug Supply Chain Security Act (DSCSA). The DSCSA applies to pharmaceutical manufacturers, distributors, repackagers and dispensers. Several of its requirements become mandatory in 2019 through 2023; however, it has become clear that many dispensers are currently not in compliance with the Act, and are not prepared to be compliant with the requirements that are soon-to-come. The FDA is currently working with the industry to determine exactly what the methods of compliance should be.
This course , presented by healthcare attorneys Melanie Bork Graham and Christopher Ezold, will address the requirements of the DSCSA, methods for compliance, the FDA’s guidance, and a discussion of how the FDA and the industry are working together to determine standards of compliance.
Discuss the DSCSA and the requirements going into effect next year and beyond
Examine potential methods of compliance for the DSCSA
Christopher acts as outside general counsel for his business clients, and advises on corporate matters, finance (startup through private equity), equity and asset purchases, mergers and acquisitions, taxation of transactions, corporate and investor rights, technology issues, contracts, operational matters, employment issues, intellectual property rights, and licensing and regulatory compliance.
Christopher works with his professional and executive clients throughout their careers, advising on career strategies, employment contracts, equity rights, taxation of deferred compensation and equity, noncompetition and nonsolicitation agreements, business and career exits, and disputes.
Christopher focuses on advising physicians and health care providers on employment, licensure, credentialing, regulatory compliance, responses to internal and government investigations, and practice purchases and sales.
Christopher provides wrap-around legal services to biotech, life sciences, and health care practices, advising not only on business and employment matters, but how to navigate the increasingly complex regulatory obligations they face, including HIPAA/HITECH, Stark and Anti-Kickback, FDA matters, OCR investigations, and more.
Christopher also represents business and individual clients in litigating commercial, business, and employment matters in trial, appellate court, and before federal and state agencies.
Christopher has been general counsel for a software and analytics company providing a blockchain SAAS solution to dispensers to comply with the Drug Supply Chain Security Act, handling corporate, licensing, finance, employment, and other matters.
Melanie Bork Graham, Esquire, is the Healthcare Practice Lead at The Ezold Law Firm, P.C. Melanie concentrates her practice on counseling health care providers and business associates. Melanie is currently a candidate for a Masters of Public Health at Thomas Jefferson University, writing her thesis on the exchange of super protected data in Pennsylvania, and is certified as a CIPP/US with the International Association of Privacy Professionals (“IAPP”).
Melanie serves as Co-Chair to the Philadelphia Chapter of the International Association of Privacy Professionals, a board director for White Horse Village, an accredited continuing care retirement community, on the Education committee the Pennsylvania Medical Management Association and formerly served on the Super Protected Data Committee of the Pennsylvania eHealth Partnership Authority.
The female presenter was incredibly knowledgeable and conveyed good judgment. Very direct, clear points. She's someone I'd feel confident in hiring as an outside lawyer. The male presenter struck me as sloppy and would not be someone I'd feel comfortable with as outside counsel.
I could tell that the speakers were very engaged in the subject matter and had a good rapport with each other. I enjoyed this session more than I expected to.
A truly eye-opening and downright scary talk about something we take for granted every day for those of us who rely on prescription meds.
The presenters were both informative and knowledgable
The presenters definitely understand and enjoy the subject matter. Good presentation.
Very professional presentation given the limited time period.
Extremely informative and well-presented!
high level presentation of very complex subject matter. presenters worked well together. a worthwhile expenditure of an hour.
I liked the update on block chain technology. Thank you for the information.