February 2018 - rfxcel.com
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[Course] Certification on Serialization and Implementation

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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
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.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING:

A Quick Guide to The EU Falsified Medicines Directive

A Quick Guide to the EU Falsified Medicines Directive

It’s a time of rapid change for the pharmaceutical industry—new procedures, laws, requirements, strategies, and technologies challenge us to engage with our products in the supply chain like never before. Many of these changes provide new visibility into the pharmaceutical supply chain to help protect patients.

The EU Falsified Medicines Directive (FMD) is one example of these changes. To help accelerate the understanding of this requirement, rfxcel has provided a Quick Guide to EU Falsified Medicines Directive to help you understand:

  1. The Key Requirements of the EU FMD
  2. Complexities Facing the Industry
  3. Preparing to Meet the Deadline

DCC Vital Selects rfxcel Serialisation Solution for EU FMD

Serious About Serialisation: DCC Vital Selects rfxcel as a EU Falsified Medicines Directive and Serialisation Solution Provider

San Ramon, CA February 21, 2018 – rfxcel Corporation, a customer-focused serialisation and track and trace provider for the Life Sciences industry, announced today that DCC Vital, a manufacturer headquartered in Dublin, Ireland, has selected rfxcel to meet its European Falsified Medicines Directive (EU FMD) serialisation requirements.

As a European manufacturer of pharmaceuticals and medical devices, and a logistics provider in the UK, DCC Vital prides themselves in their ability to deliver solutions that will make a difference to patient care.   Over the past 5 years, DCC Vital has more than doubled the scale of their business to create a focused support system for their customers in Europe, and most recently have been gaining an increased presence worldwide.  As DCC Vital continues to expand their footprint internationally, the company needed a serialisation platform that could accommodate their diverse product offering, understand the need to keep their customers at the top of their focus, and allow them the flexibility to manage their environment based on their specifications.

“DCC Vital selected rfxcel for 3 reasons,” said Conor O’Shea, DCC Vital’s Head of Information Technology. “First, rfxcel is easy to work with.  Throughout the evaluation process, rfxcel was very responsive and provided clear answers to our questions.  Second, rfxcel offers a simple pricing model that is straight forward & transparent.  Finally, rfxcel offers a customer focused architecture that allows us to manage a validated environment according to our quality standards and schedule.”

Relentless commitment to customer success and continuous innovation ensures that rfxcel’s customers meet their requirements and protect their consumers. “We are seeing a paradigm shift in the industry through recent competitive conversions, due to a lack of personalized attention from vendors.”  said Glenn Abood, CEO of rfxcel.  “Manufacturers and the entire supply chain desire timely response, support, control, and pricing transparency from their solution providers.”

rfxcel offers fixed bid contracts, which ensures customers a clear insight into their pricing model, which is not the case when contracts are based on time and material bids.  “Customers are realizing that compliance with the Falsified Medicines Directive is just the starting point. In digitizing their complex supply chains, they are seeking out partners such as rfxcel who are willing to work with their specific needs and ways of working.  We help customers to succeed, without imposing inflexible processes or the frequent changes, risk assessments and re-validations involved with other vendors,” said Mark Davison, Senior Director of Operations Europe.

To learn more about the requirements surrounding EU Falsified Medicines Directive compliance or how to build a reliable and flexible serialisation platform that suits your needs, please visit our website at EU FMD Overview.

 

For more information contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their 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.

To learn more here: Serialization Software

FAQ from EU Falsified Medicines Directive Webinar

14 Questions/Answers from the EU Falsified Medicines Directive Webinar with rfxcel serialization expert Mark Davison.

 

What is the role of a Wholesale Distributor in the EU Falsified Medicines Directive (FMD)? How does Falsified Medicines Directive require Wholesale Distributor to function? Do Wholesale Distributor need to integrate to HUB / National Systems?

A: Wholesalers integrate to National Medicines Verification System (NMVSs).
Only Good Manufacturing Practice (GMP) licensed parallel traders, who need to change the box and hence the code, would use the central EU Hub.

 

For products in Phase 3 research, when do you recommend getting ready for serialization for Falsified Medicines Directive ?

A: It is worth having the conversation with your CMO early. If CMOs have already equipped production lines, then the Marketing Authorization Holders (MAH) software part will take around six to nine months. Work backwards from planned launch date by at least a year to be safe.

 

Below what level of annual turnover do you think that corporations will not engage in this process and drop their Rx-bound activity?

A: We have seen some very small companies contemplate that step. Below about 50,000 annual units produced, it is hard to amortize costs – except for high value products.

 

What happens when MAH issues serial numbers in bulk to CMO, is it possible to track the reconciliation?

A: The rfxcel track and trace software automatically manages the issuing, reconciliation etc. between your software and the CMO, even if they ask for a buffer stock of numbers in advance.

 

Is decommissioning accepted at packing line level?

A: Yes. Until product data is uploaded to European Medicines Verification System (EMVO) (which must be at or before QP release of the product) any data manipulations are fine as long as they are tracked and auditable.

 

Is there any penalty foreseen in case a corporation or country is not ready on time?

A: Apart from reputation and embarrassment, I don’t see how a country could be penalized. For corporations, it is simple. No codes, no sales.

 

Where is the legislation in regards to NMVO contracting?

A: The countries of the EU are at different states of readiness. Some NMVOs are running pilots and getting people connected, others are not yet fully set up. The fee and contracts for those connecting to them are not specified in the FMD and are at the discretion of the NMVO.

 

How ready are pharmacies?

A: Not very, in most countries.

 

Does MAH Level-4 system needs to exchange the data with CMO Level-4 or Level-3?

A: In the case of rfxcel, both are possible. Typically, it would be between Level 4 systems.

 

For the EMVO on-boarding process:

What title/function is generally seen and/or expected as the Single Point of Contact (SPOC) within an organization?

A: Can be anyone but should be the person able to answer and deal with queries etc.

What role/function generally handles the registration/on-boarding within an organization—Regulatory, Supply Chain, Commercial? Is this is the same as the SPOC? 

A: Varies by company. Someone must sign as a legal designate of the corporate entity (i.e. senior person) but the onboarding can be done by anyone.

 

Where can I go to get more information on the on-going/annual fees associated with MAH per country? 

A: https://emvo-medicines.eu/mission/emvs/#countries

 

I’m getting management pushback backed by external counsel, that there is no legal foundation to join NMVOs. Do you have one example in national legislation of stated requirements?

A: EU Directive 2001/83/EC, Article 54a/2/e (as amended by the provisions of Directive 2011/62/EU, commonly known as the Falsified Medicines Directive) says that the cost of the repositories system shall be borne by the manufacturers. In the UK, the Falsified Medicines Directive is transposed as-is through the Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] which came into force on 20 August 2013.

 

Will Brexit make any difference?

A: In my opinion, no – for a couple of reasons.

The immediate timing of the FMD will be before Brexit, and with the 20-month transition time that is built in, this will allow the UK to carry on with any rules which are to be enforced during that period. So, for at least 2 years after the FMD, Brexit will have no effect, by law, on FMD enforcement.

The UK is such a large manufacturing country; I would be astonished if they diverge away from the rules that apply to the rest of the EU Union.

 

Do you think that the FMD could be delayed, similar to the DSCSA delay by the FDA?
A: No one knows the true answer to that. However, it could be quite possible if we are nearing the 2019 deadline and a sufficient number of organizations are not ready. With that said, I would not want to be the guy who has to explain to his superiors that we chose not to prepare ourselves, as we were counting on a delay that did not occur. We now cannot sell product for 6 months and need to take that time to catch up. My suggestion would be to not bank on it.

 

Will everyone be ready on 2/9/19?

This is the largest IT project in recent years; nearly 30 countries and the entire pharmaceutical supply chain is involved here. The chances of absolutely everyone being ready on day 1 are nil, but we all need to make our best effort to do everything we can to help this process be the best it can. It won’t be perfect, but it will be a whole lot better than what we have today.

 

Listen to the full webinar here.

Or copy/paste this link in your browser: /webinar-eu-falsified-medicines-directive/

Serialization for Virtual Manufacturers

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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.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING:

 

 

Webinar: EU Falsified Medicines Directive

EU Falsified Medicines Directive webinar that will 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 are discussing:

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.

 

Please check out the FAQ from the EU Falsified Medicines Directive webinar.
Or copy/paste this link in your browser: /eu-falsified-medicines-directive-webinar-faq/

 

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.

 

For more information contact us.

rTS 6.0: New Traceability Solution

rfxcel Traceability System 6.0:  New Traceability Solution Delivers Improved User Experience and Performance

San Ramon, CA February 7, 2018 – rfxcel, the leader in Life Science track and trace, and compliance systems, today announced the release of rfxcel Traceability System (rTS) 6.0.  The new traceability software delivers increased usability and performance which is powered by the new rTS 6.0 architecture and technology stack.

rTS 6.0 is built upon an enhanced architecture that provides greater scalability; allowing new features to be quickly added.  The new product gives users improved visibility into their supply chain via a new, highly responsive user interface (UI) and enhanced report features. Better search capabilities, menu navigation, event relationships, event notifications and alerts, and user configuration options have been added as part of the functional and UI improvements.  rTS 6.0 has been further optimized to deliver up to 3X performance improvement for critical processes.
To learn more, visit /rfxcel-traceability-software-release-6-0/

“rTS 6.0’s cutting-edge architecture makes fast, easy data insight a reality for all customers. We’re incredibly proud of the work the rfxcel team has done to deliver this game-changing serialization and compliance technology, and most importantly, make it a seamless upgrade for our customers. rfxcel brings increased visibility and flexibility to supply chain traceability and product serialization, making data more assessable than ever before.” – Atul Mohidekar Chief Technology Officer at rfxcel.

The rTS 6.0 platform is designed to simplify and accelerate how customers can meet their compliance, serialization and track and trace requirements. By leveraging a new architecture and optimization techniques, customers can be confident that their investment will meet their current obligations and scale to meet their future needs.

To learn more about how we can help you with your needs for compliance, serialization, and track and trace, please visit us at www.rfxcel.com.

 

For more information, contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their 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 Traceability System – Software Release 6.0

rfxcel Traceability System 6.0:  New Traceability Solution Delivers Improved User Experience and Performance

Request a demo for rfxcel Traceability System

rfxcel, the leader in Life Science track and trace, and compliance systems, today announced the release of rfxcel Traceability System (rTS) 6.0.  The new traceability software delivers increased usability and performance which is powered by the new rTS 6.0 architecture and technology stack.

rfxcel Traceability System 6.0 is built upon an enhanced architecture that provides greater scalability; allowing new features to be quickly added.  The new product gives users improved visibility into their supply chain via a new, highly responsive user interface (UI) and enhanced report features. Better search capabilities, menu navigation, event relationships, event notifications and alerts, and user configuration options have been added as part of the functional and UI improvements.  rTS 6.0 has been further optimized to deliver up to 3X performance improvement for critical processes.

“rTS 6.0’s cutting-edge architecture makes fast, easy data insight a reality for all customers. We’re incredibly proud of the work the rfxcel team has done to deliver this game-changing serialization and compliance technology, and most importantly, make it a seamless upgrade for our customers. rfxcel brings increased visibility and flexibility to supply chain traceability and product serialization, making data more assessable than ever before.” – Atul Mohidekar Chief Technology Officer at rfxcel.

The rTS 6.0 platform is designed to simplify and accelerate how customers can meet their compliance, serialization and track and trace requirements. By leveraging a new architecture and optimization techniques, customers can be confident that their investment will meet their current obligations and scale to meet their future needs.

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their 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.