Now that IDMP is real, is your RIM roadmap on the right track?

Now that IDMP is real, is your RIM roadmap on the right track?

WEBINAR ON DEMAND

Now that IDMP is real, is your RIM roadmap on the right track?

After all the preparations for IDMP, it’s here. But compliance will be a staged, iterative affair as requirements evolve.

The key, then, is to establish whether your organization is on the right path to ensure long-term alignment with the demands of IDMP.

About the webinar

We’ll set out the most common scenarios pharma companies will typically be starting from, exploring the options in each case.

Scenario 1: No formal RIM system currently in place
Scenario 2: Existing RIM investment: build on it – or start afresh?
Scenario 3: Single RIM vendor vs best-of-breed applications – can IDMP solution be implemented into the existing RIM landscape?

In the webinar, we’ll work through each scenario, discussing the different options – and explore the merits of performing a low-risk/low-cost IDMP proof-of-concept alongside those existing RIM set-ups to check the preferred choice is fit for purpose.

About the speakers
Renato Rjavec

Renato Rjavec

As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry.

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Challenges and best practices for global patient engagement

Challenges and best practices for global patient engagement

WEBINAR ON DEMAND

Challenges and best practices for global patient engagement

Global clinical trial success hinges on culturally appropriate patient engagement.

Discover best practices to recruit and retain study patients in global clinical trials as well as delve into the biggest challenges in this area today.

 

 

 

 

About the webinar

Join our experts as they share their real-world experiences and successes with global and cultural adaptation for effective patient recruitment and retention.

These experiences touch on methods to overcome geographical, financial and educational barriers. Learn how your language service provider can support culturally appropriate and medically accurate language services and partnerships between study operations.

About the speakers
Stéphane Millet

Stéphane Millet

Stéphane is responsible for developing strategic processes that will drive operational excellence within the Acolad Group and for ensuring the optimization of workflows and localized content for a highly regulated industry. Prior to joining Acolad in 2010, Millet worked as a translator and localization project manager in diverse operational functions. He is also a graduate of the faculty of translation studies, linguistics and cultural studies of the Johannes Gutenberg University in Mainz/Germersheim, Germany.

 

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Unlocking the business benefits of text mining in regulatory operations

Unlocking the business benefits of text mining in regulatory operations

WEBINAR ON DEMAND

Unlocking the business benefits of text mining in regulatory operations

Find out how companies can approach IDMP data collection and quality challenges and decrease associated costs.

Learn how your company can reach major time and cost savings as well as other business benefits using advanced text mining in the context of regulatory information management.

About the webinar

With the advance of IDMP implementation, data is becoming a key asset for the life sciences industry. Pharma companies are currently focusing on the heavy burden of initial IDMP data collection, but looking ahead, data maintenance will become their prevalent issue. This can only be tackled by maintaining the quality and integrity of data at all times. Making sure your data and content are always up to date, and FHIR messages are fully aligned with the content of submitted eCTD sequences, would bring major time and cost savings as well as other business benefits for the industry.

Advanced text mining technologies in the context of end-to-end RIM can support the current and future regulatory operations challenges alike. You are kindly invited to attend our webinar where some of those challenges, as well as their respective solutions, will be presented by Kelly Hnat from K2 Consulting, Hanno Ebsen from Averbis, and Renato Rjavec from Amplexor.

About the experts
Kelly Hnat

Kelly Hnat

Kelly is a leader in RIM and IDMP with 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations. Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS subteam, and the SPOR EU Implementation Guide Focus Groups. Additionally, she is a member of ISO TC215/WG6 (the ISO group responsible for the IDMP standards), is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President and CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly is the founder of K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.

Hanno Ebsen

Hanno Ebsen

Hanno holds a Master’s degree in Psychology and has more than 18 years of experience in the life science industry. After 15 years in management at a consulting firm, he moved into AI product development for pharma. At Averbis, he is the first point of contact for customers in the Life Sciences sector.

Renato Rjavec

Renato Rjavec

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Enabling efficient Submission Content Management & Publishing

Enabling efficient Submission Content Management & Publishing

WEBINAR ON DEMAND

Enabling efficient Submission Content Management & Publishing

Find out how companies can improve business agility by producing and managing compliant, high-quality submissions in a cost and time-efficient manner.

Learn how to improve submission management and publishing capabilities.

About the webinar

Submission Management & Publishing is a critical activity in Regulatory Operations with an ever-increasing need for cost and time efficiency while accommodating the flexibility to quickly react to changes or urgent submission needs. It became an essential part of the overall Regulatory Information Management process throughout the past years, instead of being an isolated domain in the operations space.

Many companies succeeded in establishing well-defined Submission Content Management & Publishing processes stretching from the global to the local organisation, including many processes and content contributors and consumers like the service providers supporting the company’s delivery needs. Recently, additional attention is being paid towards automation of routine tasks within and beyond Submission Content Management & Publishing activities to further improve efficiency and reduce human errors.

In this webinar, we’ll discuss key success factors and improvement possibilities in the area of Submission Content Management & Publishing in the context of E2E process, system, and data optimizations including:

  • Global/Local Submission Management & Publishing;
  • Submission Process Connectivity;
  • Submission Data Connectivity;
  • Submission Content Planning;
  • Submission Automations;
  • Submission Analytics;
  • Submission Simplification & Usability.
About the speaker
Agnes Cwienczek

Agnes Cwienczek

Agnes Cwienczek is Head of Product Management and Consulting at Amplexor Life Sciences. Agnes’ main responsibilities are the provision of business and compliance requirements for the Amplexor Life Sciences Suite, the supervision of the Life Sciences Consultants and the delivery of process and data management expertise to Amplexor clients in Regulatory Information Management, including Document Management, Submission Management and Labeling Management.

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Amplexor Life Sciences Product Update: Q3/2021

WEBINAR ON DEMAND

Amplexor Life Sciences Product Update: Q3/2021

Discover if your organization is on the right path to ensure long-term alignment with the demands of IDMP.

This customer-exclusive webinar will teach you about our recent product enhancements and future plans.

About the webinar

The webinar will present an overview of the recent platform (myProcess 6.4, myPress Suite 5.4) and solution (Life Sciences Suite 5.4) release updates.

We’ll also take a peek into upcoming releases related to IDMP, submission management and other topics.

About the speaker
Renato Rjavec

Renato Rjavec

As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry.

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MDR Long Term Compliance and Global Translation Readiness

MDR Long Term Compliance and Global Translation Readiness

WEBINAR ON DEMAND

MDR Long Term Compliance and Global Translation Readiness

Discover 5 crucial changes to technical documentation and how these are going to impact Medical Devices manufacturers.

The new MDR is now in effect but there is still a lot of work to be done to ensure long term compliance and readiness.

About the webinar

Our regulatory and globalization experts reviewed strategies for MedTech companies, to implement for long term MDR compliance.

Learn 5 key changes to technical documentation that impact Medical Devices manufacturers. Discover globalization strategies around product labeling, quality reporting and post market surveillance. This includes approaches to streamline change management, volume updates, and continuous translations.

About the speakers
Aline Dirven

Aline Dirven

Consultant Regulatory, Medical Devices, Zwiers Regulatory Consulting

Eline Dirven is a regulatory affairs consultant at Zwiers Regulatory Consultancy with a passion for medical devices. She has a background in biomedical sciences (research) and her experience ranges from device development to maintaining devices on the European market. Her expertise is not only limited to regulatory affairs, but also includes quality assurance such as ISO 13485 auditing, aligning procedures with latest (regulatory) requirements and providing trainings.

 

Anne Ertlé

Anne Ertlé

Sr. Director Language Services, Amplexor Life Sciences

Anne Ertlé is Sales Director for EMEA and ASPAC at Amplexor Life Sciences. A seasoned Life Sciences executive, Anne has helped pharma companies streamline their labeling processes. Her global business development and leadership skills are focused on growing pipelines in diverse environments. A French national, Anne has lived in France, the United States and Asia.

 

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