Visit us at the 2nd Pharmaceutical Regulatory Affairs Summit

Visit us at the 2nd Pharmaceutical Regulatory Affairs Summit

We will exhibit at the forthcoming 2nd Pharmaceutical Regulatory Affairs Summit, which will be held in Vienna on 26-27 October. The Summit is designed to explore the most interesting regulatory topics of 2022, including regulatory status during COVID-19, decentralised Clinical Trials, new professional strategies in 2022, statistic of data in regulatory daily basis, hot issues in pharmaceutical regulatory industry and many others.  

We will also present on: “5 essential IDMP readiness checkpoints for your future-proof RIM platform”. Other topics to be explored during the Summit include: 

  • Company’s sustainability commitment: What priorities should be on the top of regulatory affairs’ agenda? 
  • COVID-19 vaccines and treatments: Why is it important for regulators to have further discussions in regulatory forums for being in “harmony” with pandemic consequences? 
  • How to simplify work: Collecting, collating and evaluating scientific data? 
  • Regulatory labelling challenges: Communicating proper use and risk of a medicine by both the summary of product characteristics and product license 
  • Global public health emergency scenario: Why is it important to expedite regulatory steps? 
  • Collaboration with regulatory authorities: How to secure early engagement and dialogue? 
  • An overview on growing demand of new professional strategies in 2022 
  • How are strong results from regulatory approvals changing therapies for disease, while weaker results may dull hope and shut testing down? 
  • Machine learning (ML): Building algorithm to make accurate prediction and act 

 

“The 2nd Pharmaceutical Regulatory Affairs Summit is an opportunity to discuss some of the more pressing challenges facing our industry,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “That’s why we are delighted to provide a presentation based on our deep expertise in the field of IDMP.” 

 

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Visit us at TOPRA 2022

Visit us at TOPRA 2022

Visit us at TOPRA 2022

We will exhibit at the forthcoming TOPRA Annual Symposium in Vienna on 17-19 October. The Symposium, which encompasses human pharmaceuticals, medical devices/IVDs and veterinary medicines, brings together key regulatory professionals from big pharma, small and medium-sized enterprises, regulatory agencies, biotech, service providers, consultants, academia, patient groups and legal services.

The Symposium, held yearly since 2004, is the premier conference in Europe dedicated to healthcare regulatory affairs, with a programme encompassing the topics most relevant to those working in healthcare regulatory affairs, whether for human or veterinary medicines, medical devices or IVDs. The conference also includes a one-day session devoted to regulatory affairs related topics of particular interest to those working for start-ups, at SMEs and in academia.

The Symposium is open to anyone interested in regulatory affairs and gathers delegates, speakers and exhibitors from industry, regulatory bodies, support services (consultants, recruiters, translators) and connected areas (patient groups, charities, healthcare professions, legal firms, universities, notified bodies and the media).

 

“TOPRA helps our customers to access the latest information and insights while networking with thought leaders in healthcare,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “Our presence at both events will allow our customers to get up to date with our product news, including the latest releases and updates.”

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Visit us at RAPS Convergence 2022

Visit us at RAPS Convergence 2022

Visit us at RAPS Convergence 2022

RAPS Convergence 2022 returns in-person, bringing industry professionals and regulators together to co-create, problem-solve and discuss global and local challenges facing professionals in the regulatory life sciences community.

It will be thrilling to return to a face to face gathering of such prestigious individuals and companies in Phoenix from September 11-13. This is a great opportunity to take stock of the impact of the past few years and take the pulse of the wider life sciences industry.

The Amplexor Life Sciences team can be found at Booth 612. If you would like to schedule a meeting with us at RAPS Convergence 2022, please fill out this form. 

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Visit us at DIA 2022 Global Annual Meeting

Visit us at DIA 2022 Global Annual Meeting

Visit us at DIA 2022 Global Annual Meeting

For the first time in several years, the DIA 2022 Global Annual Meeting returns in-person, bringing industry professionals, regulators, academics and patients together to co-create, problem-solve and discuss global and local challenges facing professionals in the life sciences community.

It will be thrilling to return to a face to face gathering of such prestigious individuals and companies in the great city of Chicago. This is a great opportunity to take stock of the impact of the past few years and take the pulse of the wider life sciences industry.

The Amplexor Life Sciences team can be found at Booth 2039. If you would like to schedule a meeting with us at DIA 2022, please fill out this form. 

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Amplexor Life Sciences’ annual Be The Expert conference

Amplexor Life Sciences’ annual Be The Expert conference

Amplexor Life Sciences’ annual Be The Expert conference

Amplexor Life Sciences’ annual BE THE EXPERT conference brings together leading global subject matter experts to explore the latest trends in IDMP, RIM, Labelling and Quality.

We are happy to unveil the agenda for the upcoming Be The Expert conference, a virtual gathering of prominent life sciences industry professionals, including Kelly Hnat of K2 Consulting, Steve Gens of Gens & Associates, Iperion’s Remco Munnik and Tris Nockles from IRISS-Forum.

Be The Expert 2022 will be staged as a three-day virtual event, accessible online between June 7 and June 9, focusing on the key trends driving life sciences today. Sessions will examine a wide range of topics, from risk management in pharma to how cloud solutions can reduce volatility and IDMP’s impact on labelling and submission.

As one of several high-profile industry thought leaders, Steve Gens will provide insight into how companies are evolving and investing in the near and longer term in RIM solutions. This session will highlight key learnings from the 2022 Q2 Gens & Associates World Class RIM benchmark of 70 + companies, as well as the recent COVID-19 Regulatory Impact follow-up study, with an emphasis on advanced technology priorities, investments, and current performance levels.

The conference will also enable attendees to:

  • Keep updated on EU IDMP implementation and the Digital Application Dataset Integration (DADI) project
  • Maintain and improve compliance throughout the product lifecycle and evolving regulatory requirements
  • Improve operational efficiencies and information flows
  • Bridge current services with innovative technologies while reducing costs
  • Introduce innovations that can help drive business transformation and reinforce competitive positioning

At the same time, themed presentations will explore the most pressing issues facing life sciences professionals, including RIM/Analytics; RegOps/eSubmissions; Labelling/Artwork/ePI; Quality/Compliance; and Cloud technologies.

 

Register now for the most topical and insightful life sciences event on the calendar here.

We look forward to welcoming you to our first BE THE EXPERT virtual experience in June!

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Announcing Amplexor Life Sciences Suite 7.0 for the data-driven age

Announcing Amplexor Life Sciences Suite 7.0 for the data-driven age

Major new platform release & redesigned ProductExpert™ and SubmissionExpert™ solutions provide full support for IDMP data models & processes, and a faster and more intuitive submission management and publishing experience for users

Amplexor Life Sciences has kicked off 2022 with a new generation of our core platform and solution suite optimised for the data-driven age. Following on the introduction of Life Sciences Analytics in version 6, we have now released the next major product release package – 7.0 – across our platform and solutions.

Fast, intuitive and compliant data & submission management

This major release represents a complete overhaul of our platform and solutions in the two major areas of data management and submission management, offering users both a more futureproof suite of capabilities and a more intuitive and responsive experience to support their everyday work.

Our master and product data management solution ProductExpert 7.0 has been redesigned according to the requirements of the EU IDMP implementation guidelines v2.1. This enables our customers to bring their product data in line with the upcoming DADI data submission mandate in the EU and prepare for fuller data-driven regulatory information management in due course – as IDMP and the fuller Target Operating Model become the default means of regulatory exchange. New repository-agnostic platform capabilities allow for efficient management and reuse of IDMP data elements without duplication of data.

Linked to this, our upgraded submission management and publishing solution SubmissionExpert 7.0 supports document-level content planning; complete separation of document and submission relevant metadata; as well as in-line lifecycle management and viewing. Combined with substantial improvements to performance and the introduction of incremental publishing earlier last year, this brings the submission manager’s user experience to a completely new level.

Improved traceability

Platform improvements in myProcess 7.0, meanwhile, include redesigned audit trail actions, updated middleware component compatibility, and the discontinuation of old technology dependencies – including end of support for Internet Explorer 11 in favour of the modern Chrome, Edge and Safari browsers which are already supported.

The new version has also greatly optimised the upgrade process, making platform refreshes as smooth and fast as possible – for on-premise deployments as well as those provisioned via the cloud.

These are just some of the highlights of our new, improved platform and solution suite. As ever, we’ll continue to improve our offerings based on your feedback, incorporating new compliance requirements and shaping the industry trends as these evolve throughout 2022.

To find out more, register for our product webinars or join our customer circles contact our representatives!