Webinar: A Master Data Management Approach to IDMP

Exploring the challenges and benefits of product data management across Regulatory, Safety, and Supply Chain

The implementation of Identification of Medicinal Products (IDMP) in the EU is driving efforts towards structured data submissions and digitization of product information. The upcoming requirement has significant impact to data management and surrounding business processes in the Life Sciences industry.

Although driven as a Regulatory requirement, there is significant global impact and overlap with initiatives in Pharmacovigilance and Serialization. There are also significant potential benefits as well.

Unfortunately, many companies operate with these functions in silos – partly due to the different pace that the requirements are being rolled out in different areas. This causes problems with data consistency and master data management, and limits the potential benefits of standardization. This webinar will discuss the similarities and differences in product tracking requirements across Regulatory, Pharmacovigilance, and Serialization, and will provide insights in to how you can best kickstart a master data strategy, and attain both tactical and strategic advantage.

Key Points:

  • Implementation of IDMP in the EU and the rationales behind it
  • Overlaps in product identification and requirements across Regulatory, Pharmacovigilance, and Serialization
  • The future of product identification and the impact to industry

Speakers:

  • Katherine Novak, Advanced Consultant, Life Sciences, NNIT
  • Mark Loudon, Advisory Director, Life Sciences, NNIT
  • Christoph Krähenbühl, Senior Director, Excellis Health Solutions – An NNIT Group Company

WEBINAR – Intro to Brand Protection: Safeguarding Patients & Products from Illicit Trade Risk

Date Wednesday, January 26
Time: 9AM EST / 14:00 GMT / 3PM CET
Speakers:

  • Frederic Menardo, Vice President EMEA (Excellis Europe)
  • Sean O’Hearen, Managing Consultant and Global Brand Protection Specialist (Excellis)

Counterfeiting methods are becoming ever more sophisticated. As counterfeiters seek to exploit products entering new markets with fewer controls, serialisation compliance and brand security remain an ongoing challenge and the strength of pharma supply chains is frequently tested.

With patient safety and brand integrity a critical concern, managing and mitigating the growing risks of counterfeiting, tampering and trademark infringement in day-to-day operations is an essential component of safe and effective pharma product management.

In an age where the protection, security and traceability of medicines is constantly under the spotlight, pharma companies of all sizes must rise to the challenge of developing watertight systems and processes across their entire operation.

In this insightful hour-long <strong>FREE</strong> webinar, global pharma compliance specialists Excellis Health Solutions (part of NNIT) will explore these risks in greater detail, highlighting the key considerations every pharma company must address in 2022.

EU-FMD Alerts Management webinar

Managing EMVS EU-FMD alerts in a timely and GMP-compliant way is a legal obligation for every pharma manufacturer selling to the European market.
Over two years after go-live, it’s clear that this remains a challenge, and the volume of alerts – despite being reduced overall – will remain significant over the long-term.

Across the broad range of customers for whom Excellis operates the Alerts Management Service, we observe an alert rate of 3 alerts per 1,000 packs – making EU-FMD alerts a daily occurrence.

Every MAH therefore needs a solid, reliable, quality-compliant process, operating during EU pharmacy working hours to achieve the mandated response times – regardless of whether the alert’s source is caused by the MAH or more common supply chain factors beyond their control.

Join our Webinar to learn:

  • What are your obligations?
  • How can you manage your EU alerts in a compliant but lean way?
  • How may the future EMVO AMS integrate with your process?

To view a copy of this webinar, please click here.


Pharmaceutical Traceability Brazil: The Next Big Challenge

The Brazilian Authorities (ANVISA) have set out requirements in line with the National Medicine Control System (SNCM). Join Excellis as we talk about what that means for Pharma companies, and how you can get ready for the April 2022 deadline.

Date: January 28, 2021

Speakers:

  • Christoph Krahenbuhl, Senior Director – Excellis Europe
  • Volker Ditscher, Director Global Sales Track & Trace, WIPOTEC-OCS
    After studying electrical engineering with a focus on automation technology, he worked in the automotive industry at General Motors. Since 2007 he is active for the WIPOTEC Group, the world market leader in Track & Trace systems for marking products in various industries with unique codes. As a Project Manager Mr. Ditscher lead several hundred such serialization projects. Since 2011 he is globally responsible as the Director Global Sales Track & Trace for the relevant product division at WIPOTEC-OCS.
  • Marcelo Cozac, Director, MC Pack Equipamentos
    Marcelo is an Engineer with 24 years experience in the packaging industry and 11 years experience in track and trace application for the Pharmaceutical Industry.

To view a copy of this webinar, please click here.


5 Things to Consider as a Virtual Pharma Company

As a Virtual Pharma company, your primary focus is on the science and finding new ways to meet existing and unmet medical needs; however, there are important steps you need to follow to bring your product to market and achieve success. Commercialising your product successfully relies on how effectively you can leverage what the relevant domain experts can offer.

Presenters:

  • Christoph Krähenbühl – Senior Director (Excellis Europe)
  • Stefan Pflug – Head of Corporate Pharma Services & Sourcing (PHOENIX Group)

This webinar will help you identify what to focus on to achieve success based on our deep subject matter expertise.


 

Brexit & Pharma: Get expert advice on how to remain in control

This webinar discussed:

  • What system(s), if any, will manufacturers need to connect to from 2021 onward for the UK?
  • What will be the obligations regarding EU-FMD and serialised packs for the UK market from 1st January 2020?
  • How does this impact UK Packs shared with other markets, such as Ireland, Malta, and Cyprus?

Presenters

  • Jerome Bertin: GM at SecurMed UK, the UK NMVO
  • Grainne Hughes: VP of Business Support Operations at Almac Group
  • Christoph Krähenbühl: Senior Director at Excellis Europe

View the recording HERE.


 

5 Things to Know Before Going to Market in the EU

Date: June 10

Excellis Europe has a proven serialization track record with over 150 projects launched, 200 pack lines qualified, 50+ go-lives, 500+ CMOs/3PLs onboarded and 92 validation projects.

We will reveal the five things virtual pharma need to know about getting their product into the European market.

To view a copy of this Webinar, please click HERE.


 

Excellis Europe – Virtual Pharma webinar

Date: May 13

As a Virtual Pharma company, your primary focus is on the science and finding new ways to meet existing and unmet medical needs. However, there are important steps you need to follow to bring your product to market and achieve success. Commercializing your product successfully relies on how effectively you can leverage what the relevant domain experts can offer.

This webinar will help you identify what to focus on to achieve success based on our deep subject matter expertise.

To view a copy of this Webinar, please click HERE.


 

Russia Readiness Webinar

Date: January 10

Pharmaceutical companies who need to ensure supply chain compliance with the Russia regulations now have until 1 July 2020 to do so. The original 1 January 2020 deadline has been pushed back by six (6) months after a legislative development in Russia over the Christmas period.

In this webinar, we will talk about the following:

  • Find out what the deadline means for pharma companies inside and outside of Russia
  • Get the latest update from our recent face-to-face meeting with our partners at CPRT
  • Learn how to best prepare for the deadline
  • Find out how Excellis can help you

To view a copy of this Webinar, please click HERE.