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Russian Pharma Compliance Update

An IQPC & rfxcel Webinar

By Mark Davison, rfxcel

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Mark Davison is the Vice President of International Business for rfxcel. He is a leading traceability and digital health expert, specializing in the Internet of Things (IoT), traceability, and blockchain solutions. The author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”, Mark specializes in global health and big data issues that affect key industries such as pharmaceuticals, food/beverage, and fast-moving consumer goods (FMCG). His expertise lies heavily in serialization, supply chain security, patient safety, and government policy. He resides in the United Kingdom.

Please fill out the form below to get access to the webinar recording.

 

 

Everything You Need to Know About the Russian Serialization Requirements

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This webinar will cover the full scope of the serialization requirements in Russia, including all mandatory labeling requirements for 2019 and 2020.

In recent years, the serialization landscape has undergone drastic changes, with a number of new regulations coming into force. This has drastically impacted operations for many pharmaceutical companies.

There are still new changes on the horizon, with one of the most complex regulations quickly approaching from Russia.

By 2020, all pharmaceutical companies distributing in Russia must have complete unit and batch level traceability.

Considering the length of time needed to implement changes, if companies want to be compliant in time for the deadline and continue their current distribution strategy they must prepare now.

Over the course of this webinar, Mark Davison, Vice President of International Business at rfxcel will share:

  • Insight into the full scope of the serialization requirements in Russia
  • The mandatory labeling requirements to meet in 2019 and 2020
  • What you need to do now in order to be compliant by the deadline

You will walk away with answers to key questions, such as:

  • How should I prioritize efforts for each drug line to ensure compliance?
  • How should you navigate the new reporting system?
  • How can you best manage the complexities of this serialization project?

To limit the impact on your distribution strategy when this regulation comes into force, use this webinar to kick-start your preparations and understand how these changes will affect you.

About Mark Davison:

Mark Davison is the Vice President of International Business for rfxcel. He is a leading traceability and digital health expert, specializing in the Internet of Things (IoT), traceability, and blockchain solutions. The author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”, Mark specializes in global health and big data issues that affect key industries such as pharmaceuticals, food/beverage, and fast-moving consumer goods (FMCG). His expertise lies heavily in serialization, supply chain security, patient safety, and government policy. He resides in the United Kingdom.

 

Please fill out the form below to get access to the webinar recording.

Russian serialization requirements

Brazil ANVISA’s National System for Medicines Control (SNCM)

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Please join rfxcel on July 30, for a webinar about upcoming serialization requirements in Brazil. The webinar recording will be available to all who sign up below.
The Brazilian Health Surveillance Agency, commonly known as ANVISA is the food and drug regulatory agency in Brazil. ANVISA’s mission is “to protect and promote public health and to intervene in the risks caused by the production and use of products regulated by health surveillance.” Our webinar presentation will include the following main topics of the regulation set into place by ANVISA:
– Overview of the local regulations – The ANVISA SNCM
– Serialization Best Practices – Lessons learned in more than 1000 implementations
– Value Beyond Compliance and Supply Chain 4.0
– Call to Action / Next Steps

 

A brief Q/A session will follow the presentation. All who register will receive a copy of the webinar.  Even if you cannot attend on the scheduled date, please register anyway so we can send you the information being presented.

 

Disclaimer: This webinar is for educational purposes only; it is the informed opinion of rfxcel, not formal regulatory advice. We try to ensure accuracy, but we make no warranty or guarantee. We advise all attendees to confirm their own obligations directly with local regulators. Service Providers and Consultants can request to join by sending a separate email to rfxwebinars@rfxcel.com. At this time, rfxcel does exercise the right of refusal into this webinar presentation.

 

PLEASE CONTACT US BY EMAIL AT rfxwebinars@rfxcel.com OR FILL OUT FORM TO ACCESS WEBINAR RECORDING:

Verification Router Service (VRS) Update and Overview

Join rfxcel to learn about supply chain management and regulatory requirement:

VRS BASICS
Have No Clue About the Verification Router Service? Contact Us Learn the Basics:
1. FDA/DSCSA Requirements for Saleable Returns
2. An Introduction into the Verification Router Service (VRS)
3. rfxcel’s VRS Pilot Options and Demonstration

OR WANT TO LEARN ABOUT VRS EFFORTS
Understand VRS but Want to Know More? Ask about the Latest Updates on the VRS Efforts:
1. Insight into the Verification Router Service (VRS)
2. Timeline/Updates on the VRS Program
3. rfxcel’s VRS Pilot Findings
4. What’s Next for VRS – Industry Updates

CONTACT EMAIL:

hello@rfxcel.com

About rfxcel:
rfxcel is one of the most tenured track and track provider in the market today. rfxcel provides leading-edge solutions to help organizations meet regulatory compliance requirements, protect their products, and brand reputations. For the last 15 years, pharmaceutical manufacturers, wholesale distributors, and pharmacies throughout the industry have trusted rfxcel to provide more than just compliance solutions; they rely on rfxcel’s platform for greater real-time supply chain visibility and value. rfxcel is located across the globe in the U.S., EU, Latin America, India, Russia, the Middle East and the Asia Pacific. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

Serialization and Validation with rfxcel (Part 3 of 3)

Watch the short interview with Mark and Amit to learn more about our system’s architecture for data quality in a supply chain. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

Since every system, even a well validated one, is prone to errors that are flowing from outside, Mark and Amit speak about the engineering of rfxcel’s system which is designed to catch as many of those errors as possible.

Over the last three years rfxcel has consistently been able to identify almost 96% of our issues up front, before they get to our customers. Our product has the ability to pick out duplications and transmission errors between fields which other systems pass through. One of the attributes of our system is its monitoring ability which is tailored to your compliance needs.

With rfxcel you can pick a solution which partners with you and allows you to have the growth you need, while the system expands as well.

Serialization and Validation with rfxcel (Part 2 of 3)

Watch the short interview with Mark and Amit to learn more about the compliance factors and requirements that are essential when evaluating a software vendor for serialization. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

In this interview Mark and Amit discuss what questions you should be asking when evaluating a solution provider for serialization.

There are three key compliance factors you should take into consideration when evaluating software vendors for serialization, according to Amit.

The first one is maintaining your validated statement. If the vendor keeps providing you with continuous updates, you need to constantly validate to maintain the state of compliance which can be a very laborious and costly task.

The second factor to consider is how well the risk is being controlled on your end.  If the vendor keeps providing you with the risk process upfront, you as the recipient can make your own risk decisions.

The third factor to take into consideration is the transparency of the improvements that the vendor makes to the software, keeping you up to date with all the changes and improvements.

rfxcel ensures the transparency for the manufacturers, distributors and dispensers, providing the best quality of data.

Serialization and Validation with rfxcel (Part 1 of 3)

Watch the short interview with Mark and Amit to learn more about managing compliance with various traceability regulations with rfxcel. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

In this interview, Mark and Amit discuss the issues of managing compliance with various traceability regulations such as sensitivity and protection of the data quality.

Data quality is a process of managing integral parts of your data for your systems, and ensuring that, on a risk- based level, you are containing and controlling that information so unauthorized access is prevented. As a customer, you cannot rely on the system to provide you with full security. That’s where rfxcel steps in and takes it to the next level.

rfxcel provides different procedures and controls that are technical, administrative or procedural that ensure protection of customer’s data. Since it’s a holistic level of management of data and not just an enterprise level, client or system based situation, it’s a crucial aspect for companies to be very sensitive and compliant.

While rfxcel makes sure our customers are compliant, the customer also has a much invested value in ensuring the change control procedures meet standards making the customer an active partner with the vendor in going through change management. We allow our customers the opportunity to stay in a compliant state, thus having control of how your system is being addressed.

rfxcel provides not only procedural and operational guidelines, but also a full support needed in case of a compliance audit.

Value beyond compliance with IoT technology

Watch a short interview with rfxcel’s Mark Davison and Atul Mohidekar to learn more about Value beyond compliance with IoT technology. Contact us for a quick demo and case studies on rfxcel’s IoT technology.

Mark Davison, Senior Operations Director – Europe, rfxcel

Mark Davison started rfxcel’s EU and Russia operations and is responsible for devising regional strategies, hiring, and managing growth. He made Medicine Maker Magazine’s Power List of 100 most influential people in pharma manufacturing and development. Mark provides particular expertise in anti-counterfeiting technologies, authentication, serialization, traceability and vendor selection. Now he broadening his experience about value beyond compliance with IoT technology.

Atul Mohidekar, Chief Technology Officer, rfxcel

Atul Mohidekar is known for his extensive technical expertise in Big Data and is exceptionally skilled in designing highly scalable IoT solutions. Atul is adept at identifying and harnessing data to complement highly configurable IoT devices for event identification and processing for real-time analytics and data mining.

In this interview, Mark and Atul discuss the value of IoT technology to derive value from the vast amounts of data gathered through compliance efforts. Mining the data gathered through compliance efforts provides companies and organizations with the opportunity to gain new insights and complement IoT efforts with on-demand track and trace and event-driven decision making.

rfxcel Traceability Software (rTS) and in particular our Environmental Monitoring solution (rEM) are designed to monitor and track events in real-time and provide information such as location, temperature, humidity, light, and pressure. With the help of rfxcel, companies can track and trace products immediately and gain unprecedented product insights at even the unit level.  This breakthrough in supply chain technologies provides companies and organizations the ability to monitor the health of cold-chain products, deter theft and fraud, optimize supply chain operations, and manage recalls and returns more efficiently.

Watch and learn more today about the exciting new application of IoT to enhance supply chain operations and take them to next level!