Pharma Videos Archives - rfxcel.com
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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.

rfxcel Serialization Implementation Plan (Full Interview)

Learn more about rfxcel’s serialization implementation plan:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

Rose and Herb talk about the rfxcel Serialization Implementation Plan, how it is structured, configured, and implemented. By utilizing industry best practices, and understanding the needs of the clients, Rose implements rfxcel’s end-to-end traceability solution with a full-service approach and mindset.

Rose looks at validation from an auditor’s perspective which enables her to gain insight into the best practices. This approach minimizes risks of not having a good validation plan, a method which she coaches the rest of her team. rfxcel has a global Professional Service team structured by technical project managers who are responsible for a full project plan, and IT professionals who look at customer’s partner connections and integrations.

“We want our customers to recognize that we have a tremendous amount of integrity in what we do and we are there through every step of the process. We at rfxcel understand the importance of validation and qualification for pharmaceutical companies. It is important to understand how the relationship between trading partners and who is the owner of that relationship. Once we understand the structure of those relationships, it helps us understand how to configure our customer’s system.” says Rose.

On the first day of any onboarding kickoff, we make sure we understand your business plan to start a new or build on the existing implementation process of your company. Since we’ve been doing this for so many implementations over the last fourteen years, we have a standard set of documentation, templates, that we’re using. We have a set of user requirements that are well defined for the industry and make the implementation process seamless. At the kickoff meeting we’re already bringing you a development system that looks like yours, a system already ready for you. We have recipes already built in for the serialization. This approach ensures customers to know the implementation roadmap, what to expect and how rfxcel will support them in every step of the road.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have segmented this interview and discussed our Plan in 8 segments:

  1. Have an Implementation Serialization Plan with rfxcel
  2. Serialization Implementation Plan based on Audit Needs
  3. Serialization Implementation Team from Start to Finish
  4. Global Serialization Implementation Team for Global Customers
  5. A Serialization Solution Provider Focused on the Long Term Relationship
  6. Common Challenges in Serialization Implementations
  7. Implementation kick off with rfxcel
  8. Switching Serialization Providers

rfxcel Fights Against Counterfeit Drugs

rfxcel a leader in patient safety through traceability offers the solution to eliminate counterfeit drugs (counterfeit medicines)

We all use medications. Since they have such a significant effect on our health, we need to know that the medicines that we buy and consume are authentic and safe.

Looking into the world of drug supply data, we can see that 10 – 15% are counterfeit drugs. Criminals aim to scam the consumers by mislabeling drugs and selling the authentic ones on the black market. For this reason, pharmaceutical industries lose hundreds of billions in profit, and over 100 000 patients lose their lives every year.

The US Government and other nations are combating these problems with regulations such as the Drug Supply Chain Security Act (DSCSA) which demands complete visibility of the drug’s journey from the manufacturer to the patient. The hope for these efforts is to eliminate counterfeit drugs (counterfeit medicines). However, increased regulations also increase complexity for such a vast and diverse supply chain. Tracking all orders and items and making their location, status, and environmental conditions visible the entire time of their supply chain journey may seem like a daunting task, but rfxcel offers a brilliant traceability solution.

With rfxcel Supply Chain Traceability Software, rfxcel enables the supply chain participants to track their products by integrating data between manufacturers, distributors and re-packagers, clinics and pharmacies. The way the tracking works is that each shipment is assigned a serial number which is scanned at every handout by the receiving party. rfxcel instantly provides a digital report with different data points about the product and its history. This data is then aggregated in a relationship hierarchy so that the recipients can gain complete visibility into every pallet, case, and bottle. Not only does this process protect manufacturers and pharmaceutical companies by disabling criminals to mislabel drugs, but it also enables patients to feel confident that their medications are authentic and safe.

About rfxcel Supply Chain

rfxcel is the leading enterprise software for supply chain and traceability. rfxcel Supply Chain Traceability Software module provides full visibility of the product supply chain: from the incorporation of ingredients used in the manufacturing process to the distribution of the final product to the end consumer. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring.

rfxcel is here to provide the industry the solution that best fits their needs and requirements. For more information, please contact us.

 

Counterfeit Drugs