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DSCSA Guidance, Q&A Session, with Brian Files, DSCSA Strategic Advisor

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DSCSA Guidance and FDA explain the latest enforcements and changes in the regulation.

Do you have questions about the enforcement delay of the DSCSA? Not sure what this means for you?
Brian will answer your questions, explain exactly what you have to do to comply, and give insights into the DSCSA as we move into 2021.

Once registered, you will receive a confirmation email. Please note that given the nature of this session, we will rely heavily on your questions and how we can best serve you. Please let us know what you are wondering about by sending your questions to marketing@rfxcel.com or by bringing them with you to the webinar and simply entering them into the chat at any time during the call.

In the meantime, check out rfxcel’s latest blogs on this topic: FDA Delays Enforcement of DSCSA Saleable Returns Requirement and Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns.

Download DSCSA Guide here

About Brian Files:
Brian Files is rfxcel’s DSCSA Strategic Advisor and principal and founder of BBF Consulting, LLC, and an expert on the U.S. and international pharmaceutical and healthcare supply chain compliance. He has an M.B.A. from the University of Michigan and a B.A. from Cornell University.

We are looking forward to the opportunity to speak with you soon!

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Serialização & Rastreabilidade Conforme o SNCM – ANVISA

 PT: Webinar ao vivo com Q&A: Visão Geral das Regras do SNCM – ANVISA, e Standards para Serialização & Rastreabilidade para Indústria Farmacêutica
Live Webinar with Q&A: Overview of the ANVISA Regulations, Industry Traceability & Serialization Standard
PT: Segunda, 7 de dezembro das 11:00 AM – 11:30 AM (BRT) 
Monday, December 7 from 11:00 AM – 11:30 AM (BRT)   
PT: Apresentado por: Vinicius Bagnarolli – Diretor – América Latina
Presented by Vinicius Bagnarolli – Diretor – América Latina
PT: Saiba mais sobre as últimas atualizações do Sistema Nacional de Controle de Medicamentos da ANVISA e como se preparar para atender a regulação
Learn about the latest information about ANVISA regulations and what is required from you. 
 
Registre-se aqui:
Register here:
https://attendee.gotowebinar.com/register/4489140361063737104
Para receber uma cópia da gravação, envie um email para latam@rfxcel.com
To receive a copy of the recording please email us at latam@rfxcel.com

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:

The EU Falsified Medicines Directive – for the Pharmaceutical Dispenser

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SEP 26, 2018

Please join rfxcel for a webinar that will provide insight into the upcoming serialisation requirements of the EU FMD and how this relates specifically to Dispensers. In this 45 minute presentation, we will discuss:

1. Overview of the key features of the FMD
2. What the FMD means for Dispensers: Who does what and when are they expected to do so
3. What to think about when selecting a FMD solution provider
4. Stand alone FMD solution versus those integrated with pharmacy software – Pros and Cons
5. How installation and roll-out is performed

About our Speaker:

Mark Davison, based out of the UK, is a leading traceability and digital heath 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. Mark is currently the Senior Operations Director for Europe, at rfxcel, and is looking forward to the opportunity to share his expansive knowledge on this topic.

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Serialization Requirements in Russia

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MAY 29, 2019

Please join rfxcel for a webinar on 29 May to learn more about the upcoming Serialization Requirements in Russia. During this 45 minute long presentation, we will shed some light into a highly complex set of serialization requirements. All parties involved in the manufacturing of and the distribution of medications in Russia, must comply with these requirements. We will also allow time at the end for a brief Q/A session. The main topics of discussion during this webinar presentation will be:

– An Overview of the Global Serialization Landscape
– A Detailed Explanation of the Serialization Requirements in Russia
– Mandatory Labeling Requirements for 2019 and 2020
– How these Requirements Apply to the Pharmaceutical Industry
– What Do I Need to Do Now in Order to be Compliant by the Deadline?

Please note that we encourage registration for this webinar even if you are unable to attend at the scheduled date/time. All approved attendees will receive a copy of the webinar following the presentation. This webinar is merely for educational purposes and is our informed opinion, not formal regulatory advice. We try to ensure accuracy, but we make no warranty or guarantee. Attendees are advised to confirm their own obligations directly with local regulators as necessary. At this time, rfxcel does have the right to exercise refusal into this webinar presentation.

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VRS UPDATE – Understand VRS but Want to Know More? Hear the Latest Updates on the VRS Effort Here

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FEB 27, 2019

Join us for Webinar #2 in a 2 part series on the Verification Router Service (VRS). During this 45 minute long presentation, including time for live Q/A, we will discuss the following topics:

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

Please note that this presentation will be recorded and a copy will be sent to all registrants following the webinar’s conclusion.

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How Unique Identifiers (Serialization) are Changing the Traceability Game

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DEC 6, 2018

Managing global supply chains and validating the origin of ingredients is a major challenge. The consequences for mislabeling, fraud, adulteration or a food safety recall can be devastating to your organization’s reputation and bottom line.

Join rfxcel for a webinar to learn how we can help you track ingredients and raw materials through to finished goods; providing you with a heightened ability to validate your brand claims, mitigate risks, and gain unprecedented insights into your supply chain operations. We will share with you how we can assist with this process by means of unique identifiers (serialization) & a level of prodigious customer engagement opportunities. We will also share with you how this degree of transparency will allow your organization insight into how consumers are responding to your product(s) as well as visibility into valuable data such as freshness and origin.

We hope that you can join us and we encourage you to register via the link below. This event will be recorded and a copy will be sent to all registrants following the presentation. If you have any questions in the meantime, please email us at rfxwebinars@rfxcel.com

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Data Integrity in the Pharmaceutical Supply Chain

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JUN 20, 2018

Please join rfxcel for a webinar presentation regarding Data Integrity in the Pharmaceutical Supply Chain. During this 45 minute recorded 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 heath 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.

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