The EU Falsified Medicines Directive: Data Integrity in a Serialized World

Register HERE

Please join rfxcel for a webinar presentation regarding Data Integrity in the Pharmaceutical Supply Chain. During this 45 minute webinar, we will cover the areas of :

1. Why data integrity is only as good as the weakest link

2. How data errors can occur in validated systems

3. Why active error checking is needed.

4. What regulators are planning

5. How you can prepare

This webinar will be hosted by Mark Davison, Senior Operations Director in Europe, at rfxcel. Mark 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 serialization, supply chain security, patient safety and government policy.

Please note that this webinar will be recorded, and a copy of this session will be sent to all attendees. If you are unable to attend this webinar but would like to receive a copy following, please register below and we will oblige accordingly.

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.

 

rfxcel EU FMD Webinar
rfxcel EU FMD Webinar

DSCSA for Wholesale Distributors

DSCSA for Wholesale Distributors: 

Wednesday, April 18, 2018

PDT: 10 a.m. | EDT: 1 p.m.

Register here

 

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 Main points to note: FDA Grandfathered Draft Guidance 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.

 

DSCSA for Wholesale Distributors rfxcel

EMVO Onboarding & EU Falsified Medicines Directive

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

Thursday, March 29, 2018

16.00 BST / 17.00 CEST / 11:00 AM EDT

 

Register here

 

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.

 

EMVO Onboarding rfxcel
EMVO Onboarding rfxcel

[Course] Certification on Serialization and Implementation

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
Price: $299 | Course is offered in collaboration with other Life Science leader.

Learn more how to get your Certification on Serialization here.

Please note, rfxcel will receive no premium. rfxcel is providing content with the sole purpose of educating students.

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

Learn more here.

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

At the completion of this session, you will:

  • 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 ATTEND

This course will be of benefit to anyone working in a regulated environment on global or domestic scale that manages the product life cycle, develops products that fall under serialization, and compliance laws and manage the quality of products.

This includes personnel in:

  • Quality
  • Compliance
  • Serialization
  • Manufacturing
  • Supply Chain
  • IT

Don’t miss this opportunity to earn a Certification on Serialization with rfxcel and industry leaders.

Certification on Serialization

Serialization for Virtual Manufacturers

Wednesday, February 28th, 2018

PST: 10 a.m. | CST: 12 p.m. | EST: 1:00 p.m.

Register Here. 

Or copy/paste this link into a new URL:

https://attendee.gotowebinar.com/register/8609688806476560897

Please join rfxcel for a webinar that will provide insight into how to meet Serialization Compliance Requirements for the Virtual Pharmaceutical Manufacturer. Even though Virtual Manufacturers may out-source their manufacturing, they are still responsible for the validity of the serial numbers and the timely reporting to government regulators. In this hour long presentation we will provide information in the following areas:

• Discover best Serialization best practices for Virtual Manufacturers
• Learn how to manage serial numbers with your CMO’s/CPO’s
• Develop Serialization strategies that allow you to easily switch or add new CMO’s/CPO’s
• Understand the importance of data quality in a serialized world

About our speaker:

Herb Wong is rfxcel’s Vice President of Product Development and Marketing. He brings many years of technology related experience with him, and is currently responsible for defining the rfxcel product road map and marketing strategy. Herb plays a key role in the collaboration of our product development and marketing efforts.

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.

 

EU Falsified Medicines Directive Webinar: What to Know & Where to Begin

EU Falsified Medicines Directive Webinar: What to Know & Where to Begin

Presented by: Mark Davison, Serialization Expert for rfxcel based in UK

Webinar recording: https://www.rfxcel.com/webinar-eu-falsified-medicines-directive/

Also read: The EU Falsified Medicine Directive Webinar Follow-Up: 14 Answered Question from rfxcel serialization expert Mark Davison

 

 

Tuesday, January 30, 2018 – Webinar has ended!

A webinar by rfxcel to provide insight into the upcoming serialization requirements, and learn how to ensure your organization is on track to compliance. In this 45 minute presentation, we will discuss:

1. An overview of key features of the EU Falsified Medicines Directive.

2. What does this mean for Marketing Authorization Holders (MAHs), Distributors and Dispensers?

3. Who does what? The role(s) of Small or Virtual MAHs and Contract Manufacturers explained.

4. Explanation of the EMVO process, and steps to onboarding your organization.

5. Considerations when selecting a certified gateway provider.

6. Timelines, resource needs, validation and other issues.

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.