Category: webinars

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DSCSA for Wholesale Distributors: 

Please join rfxcel for a webinar that will provide insight into Phase II of the DSCSA Regulation for Wholesale Distributors. During this 1 hour long presentation, we will discuss:

1. FDA/DSCSA Activities for Wholesale Distributors 

2. Main points to note: FDA Grandfathered Draft Guidance 

3. A Timeline for DSCSA requirements 

4. The Role of the Solution Provider 

5. Top Concerns from Wholesale Distributors 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. The platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

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EMVO Onboarding & EU Falsified Medicines Directive: 

What to Know and Where to Begin

Presented by:

Fanny Trenteseaux Project Coordinator/Customer Relation Manager

European Medicines Verification Organisation  &

Mark Davison Senior Operations Director for rfxcel

Please join us for a webinar explaining the EMVO Onboarding Process and the Falsified Medicines Directive requirements; co-presented by Fanny Trenteseaux of the European Medicines Verification Organisation (EMVO) and Mark Davison of rfxcel. On this hour-long call, we will provide:

1. A brief introduction to the EU Falsified Medicines Directive/Delegated Regulation
2. Explanation of the EMVO and how to onboard your organization
3. How to choose a gateway provider (IT partner)
4. Q&A – plenty of time to get your specific queries answered

About Our Speakers:

Fanny Trenteseaux, a member of EMVO’s Commercial & Partner Management team, is a Project Coordinator and Customer Relation, Manager. She is actively assisting with the contractual on-boarding process, manages the Legitimacy Check process, and manages the Community of National Medicines Verification Organisations.

Mark Davison, Senior Operations Director for Europe at rfxcel, is a leading traceability and digital health expert as well as the published author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. Mark specializes in global health and big data issues such as serialisation, supply chain security, patient safety and government policy.

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Course: Key Elements of Pharmaceutical Serializations and, Track and Trace Systems – Implementation and Compliance Best Practices

Instructor: Terry DeMarco, Implementation Consultant for rfxcel

Duration: 90 min

Boost your knowledge about the pharmaceutical track and trace processes and systems! Learn the fundamentals of serialization, build your plan for implementation, and meet DSCSA compliance requirements.

• Learn the elements of a best-in-class serialization program, plus the regulatory and patient consequences for having anything short of “the best.”
• Discover how serialization works, and receive context for all the functional areas involved.
• Plan for strategy, implementation, and continuous improvement
• Discuss the ten-year plan to enact serialization and traceability throughout the entire United States supply chain
• Understand what GS1 is and how it is involved in the serialization project

Overview

As counterfeit drugs have become more sophisticated, the risk of knock-offs reaching patients increases every year. Naturally, counterfeit drugs can harm brand and profits, but the real victims are patients, who rely on your products to maintain their health, cure illness, or even survive. Therefore, an iron-clad approach to your supply chain is warranted, and required by law. This process of tracing the path of drugs from the manufacturing line to the patient to ensure supply chain integrity is called “Serialization,” and non-compliance is not an option.

Global governments and Health Authorities have introduced laws, issued requirements and provided processes to ensure the sanctity of the pharmaceutical supply chain. In the United States, these requirements were manifested through the Drug Quality and Safety Act (DQSA). This legislation provided the legal requirements and framework by which prescription drugs must be traced through an electronic, interoperable system. Compliance deadlines are looming, and few are ready.

This certification course on serialization will provide you with the critical elements of what is required, and how to approach your specific situation to plan for compliance. Additionally, you will be presented with best practices for implementing/improving your serialization program, and recognize common pitfalls and inspection findings.

Learning objectives

• Learn the elements of a best-in-class serialization program, plus the regulatory and patient consequences for having anything short of “the best”
• Discover how serialization works, and receive context for all the functional areas involved
• Plan for strategy, implementation, and continuous improvement
• Outline common failures and regulatory observations you should know and avoid
• Identify areas for continuous improvement

Who should download the course?