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ANVISA SNCM traceability and serialization webinar | rfxcel

Overview of the ANVISA SNCM Regulations, Industry Traceability & Serialization Standard

Presented by Vinicius Bagnarolli – Director of Operations – LATAM

WEBINAR TOPICS:
  • ANVISA SNCM Regulation overview
  • Traceability for the Pharmaceutical industry
  • Serialization Standards

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Serialização e Rastreabilidade para Medicamentos – ANVISA SNCM

Preencha o formulário abaixo para acessar o webinar sobre Serialização e Rastreabilidade.

A apresentação será realizada por Vinicius Bagnarolli – Diretor de Operações LATAM

ALGUNS DO TEMAS QUE ABORDAREMOS:
  • Visão geral da Regulamentação da ANVISA SNCM
  • Rastreabilidade para a indústria Farmacêutica
  • Padrões de Serialização



COVID-19 Healthcare Coalition: Coordinating a National Response to Counterfeit Mitigation

rfxcel is participating in a webinar presented by the COVID-19 Healthcare Coalition on December 17, 2020. Collectively, the coalition pulled together a distinguished set of speakers, including moderator Kevin Smith of the rfxcel Public Sector Team, and we are looking forward to the depth of knowledge that will be shared during the presentation. I hope that you will be able to join us, as we dive deeper into the issues our healthcare supply chain is facing amidst the COVID-19 pandemic.

This webinar is the 3rd in a series of 3. 

Title: Coordinating a National Response to Counterfeit Mitigation

Due to the COVID-19 pandemic, the healthcare industry has seen demand grow 10 to 15 times pre-COVID levels. Suppliers have struggled to keep pace with this demand, and counterfeiters have taken advantage of the situation to sell substandard products to desperate buyers. This webinar will address how industry, healthcare, and government (federal, state, and local) can work together to reduce counterfeits.

Panelists

  • Moderator: Kevin Smith, Senior Government Affairs Advisor, rfxcel
  • Dr. Alex Eastman, Senior Medical Officer-Operations, Department of Homeland Security
  • Aaron Graham, Executive Director, Brand Safety & Security, Boehringer Ingelheim
  • Sarah Hilderbrand, Chief Operations Officer, NASPO ValuePoint, National Association of State Procurement Officials (NASPO)
  • Raj Sharma, Founder and CEO, Public Spend Forum

Note: This 12:00-1:30 p.m. ET webinar is the third in a three-part series. Recordings of all webinars will be available on the rfxcel website following this presentation.

Login information: This webinar does not require pre-registration, please use the join link below.   

https://mitre.zoomgov.com/j/1612791398?pwd=SGN6L3VnSWF0ZlRGQ2ZQV3UzbkFVZz09

COVID-19 Healthcare Coalition Webinar Series on Counterfeit Mitigation: Building a Counterfeit-Resistant Procurement Environment

Wednesday, December 2, 2020 at 12-1:30 pm Eastern

 

Due to the COVID-19 pandemic, the healthcare industry has seen demand grow 10 to 15 times pre-COVID levels. Suppliers have struggled to keep pace with this demand, and counterfeiters have taken advantage of the situation to sell substandard products to desperate buyers. This webinar will address how procurement leaders and their supply chain partners manage counterfeit risks and identify the tools, resources, and practices that procurement organizations can leverage to make informed buying decisions.

 

Login information:

Join from a PC, Mac, iPad, iPhone or Android device:

Please click this URL to join. https://mitre.zoomgov.com/s/1602705055?pwd=TVpaNXE5M3BqVFpYbDV3WkJ5L2hEUT09

Passcode: 629454

 

Or join by phone:

Dial(for higher quality, dial a number based on your current location):

US: +1 669 254 5252  or +1 646 828 7666

Webinar ID: 160 270 5055

International numbers available: https://mitre.zoomgov.com/u/adcaBWlpBw

 

rfxcel Joins the COVID-19 Healthcare Coalition

 

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

Access webinar recording here

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!

This webinar ended. Please click here to request the DSCSA Guidance and recording.

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.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING: