Exploring the Drug Supply Chain Security Act (DSCSA) and its Impact to Drug Manufacturers, Wholesalers, and Pharmacies
Overview:On November 2013, President Obama signed into law The Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). DSCSA authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, adulterated, and diverted products. The law replaces State level e-Pedigree regulations.
Title I of DQSA establishes Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers – large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
Title II of DQSA known as DSCSA paves the way for an electronic tracking system to prevent counterfeited or stolen prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to track serialized medicines from manufacturing facilities to pharmacies. Pharmaceutical wholesale licensing standards, transaction verification, and lot -level tracking, requirements come into effect as early as Jan 1, 2015.
This webinar will address some important issues regarding the new law:
- DSCSA Regulatory Overview
- The Manufacturer and DSCSA
- Wholesale Distributor and DSCSA
- Dispenser Focus and DSCSA
- Re-packager / 3PL and DSCSA
- Regulatory and business implementation issues
- Key definitions for product and transaction requirements
- Serialization requirements for packages
- Product tracing (lot and unit level) of transaction history, statements, and information
- Requests for information on transaction histories
- Verification of product identity and transaction requirements
- Data retention, returns, drop shipments, grandfathering
- Network compliance timelines for supply chain participants
Vice President, Center of Excellence
- DSCSA an Overview of the law who, what and when
- Discuss the timeline for implementation and FDA actions required
- Best practice approach to compliance – What to do and when
Greg Page, MD
Life Sciences Practice Head
Deloitte Consulting LLP
Senior Manager, Life Sciences Practice
Deloitte Consulting LLP
- Preemption – Impact on existing laws, impact to industry etc
- FDA DSCSA timeline – reality vs plan
- define and discuss Transaction Information (TI), transaction history (TH) and transaction statement (TS)- what is required and when – potential impacts etc
- I might have something about the implications of an Act (regulation) vs FDA guidance doc and a summary of the June 2014 FDA guidance around ID of suspect product and notification (if needed )
Director, Advisory Services
- Aligning DQSA (DSCSA) requirements with existing business processes
- Impact to Quality System, Policies, and Procedures
- Appropriate use of technology
Associate Director,Strategic Planning and Projects
- Suspect product and Illegitimate products management
- Request for Information
Who Should Attend:
-Drug Manufacturing Administrators
-State Board of Pharmacy Administrators
-Attorneys – Pharmaceutical & Drug Manufacturing
-Public Health and Consumer Advocates
-Healthcare Network Administrators
-Package Delivery Organizations (Federal Express, UPS)
David DeJean, Vice President, is responsible for Systech’s Center of Excellence, which supports and educates customers and stakeholders on best practices for implementing Enterprise Serialization, Track & Trace and Authentication solutions. DeJean brings a wealth of market knowledge, hands-on experience in serialization solution development and project methodology. His role includes staying abreast of international regulations, business and industry drivers, and supporting customers and stakeholders, defining high performance, cost-effective solutions that are integrated and expandable to meet future needs. DeJean is a serialization subject matter expert, previously holding various roles within Systech including, Engineering Management, Product Marketing, Professional Services and Sales Management.
David DeJean, Vice President, is responsible for Systech’s Center of Excellence, which supports and educates customers and stakeholders on best …
Greg has over 25 years experience in both the Pharmaceutical and Biotech Life Science industries focusing on Quality Systems, Validation and FDA Regulatory Compliance. He has extensive experience in new business/product development and QC/QA/RA issues.
Prior to re-joining Deloitte Consulting from Navigant Consulting (where he was a Managing Director in the Life Sciences Regulatory practice), Greg was the FDA Practice Leader for Deloitte & Touche’s LS Healthcare Regulatory Practice.
Greg has held industrial management positions at the Director and Vice President level, in such companies as Hoechst (now Aventis), BASF, Bayer, the NY Blood Center/Melville Biologics and VI Technologies.
Dr. Page has extensive FDA audit experience (annual audits, licensing inspections & product meetings) and 483/warning letter/consent decree response and remediation program development. He has led a number of compliance risk assessment and remediation projects for many major pharmaceutical, biotech and medical device companies.
Greg has over 25 years experience in both the Pharmaceutical and Biotech Life Science industries focusing on Quality Systems, Validation …
Rajesh is a Senior Manager in Deloitte’s Life Sciences Practice with over 16 years of IT and Project Management experience. He has led several large scale global systems implementation and rollout programs. He has successfully managed several projects that had multiple stakeholders from business, IT and external vendors.
He is currently focused on design and implementation of drug serialization and traceability solutions for major pharmaceutical and medical device companies. He has led several large projects in this area and has deep experience in product barcoding and labeling based on GS1 and HDMA standards and guidelines.
He is currently leading a DQSA implementation project in the US for a major pharmaceutical company
Rajesh is a Senior Manager in Deloitte’s Life Sciences Practice with over 16 years of IT and Project Management experience. …
David is a director in KPMG’s Advisory Services practice with more than 20 years of operational, engineering and IT experience in supply chain execution, primarily in the pharmaceutical industry, including both clinical and commercial chains. He has a strong background in pharmaceutical order-to-cash processes, logistics/distribution operations, and supporting technical and IT platforms.
David has substantial experience in supply chain execution processes in all countries/regions of the world. He supports clients seeking technical and functional guidance with pharmaceutical product serialization and traceability requirements, as well as UDI (Unique Device Identification) requirements for device manufacturers.
David is a director in KPMG’s Advisory Services practice with more than 20 years of operational, engineering and IT experience …
Priya Gopal is a Associate director, strategic planning and projects for Novartis . She is a program manager for serialization and product tracking for Novartis , US. She has been with Novartis for more than ten years playing various global roles in strategic planning and in program management. Priya was one of the key players in integrating of newly acquired companies Nektar and Chiron to Novartis. Priya has US lead for global wide supply chain optimization program.
Priya has her MBA in finance and is a board member of PDSA (Pharma drug security alliance)
Priya Gopal is a Associate director, strategic planning and projects for Novartis . She is a program manager for serialization …
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Method of Presentation:
NASBA Field of Study:
Specialized Knowledge and Applications - 2.00 credit hours
NY Category of CLE credit:
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Deloitte Consulting LLP
Systech International is a global leader in brand protection and authentication technologies serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
Systech offers revolutionary anti-counterfeiting technologies, mobile authentication solutions, and supply chain data visibility applications that make customer’s brands more secure and the resulting data more accurate, valuable and actionable.
Based in Cranbury, New Jersey, with international headquarters in Brussels, Belgium, Systech’s dedicated sales and technical services teams serve customers in more than 26 countries worldwide.
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