RELY ON OUR TEAM

法规咨询

RELY ON OUR TEAM

法规咨询

让凯理斯的经验为您提供服务

凯理斯顾问在监管运作和合规方面有近100年的累积经验,是处理全球监管问题的专家。

通过我们的团队帮助您优化监管流程,满足不断变化、对进行产品注册至关重要的要求,让世界各地的患者都能在市场上买到您的产品。

READY FOR IDMP?

IDMP: 准备好了吗?

IDMP将使挖掘产品数据以保障病人更容易,最终拯救生命。但是,采用这些标准是一项重要的工作,需要在许多内部职能部门和外部合作伙伴之间进行仔细的规划和协调。

从2022年开始,生命科学公司可以开始提交IDMP Iteration 1,这在2023年成为强制性的。

凯理斯监管咨询可以帮助您。让您对IDMP准备和合规战略充满信心。

与我们的专家讨论

与我们的专家讨论

将凯理斯资深监管专家的深厚和多样的经验运用到您自己的监管团队。

今天就安排与凯理斯监管顾问的会面吧

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CALYX-20-Headshots-KarenHarry2-FINAL

Director, RIM

Karen Harry

Karen has over 30 years of industry experience in regulatory operations, information management, and compliance, and is currently a member of the EMA SPOR Taskforce supporting the implementation of IDMP iteration 1. As head of Calyx RIM Consulting, she leads a team of regulatory experts who provide strategic regulatory input into the software development lifecycle of Calyx RIM and advise clients on how to effectively manage complex regulatory processes in alignment with the changing regulatory landscape.

 

LinkedIn Profile

 

 

CALYX-20-Headshots-DarrenOaks-FINAL

Manager, Regulatory Implementation

Darren Oakes, PhD

Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained within Regulatory Information Management, Regulatory Affairs, Compliance and Quality Assurance. He currently provides regulatory and consulting services for the implementation and operational use of the Calyx Regulatory Information Management (RIM) system, specializing in EU procedures, XEVMPD, IDMP and Combination Products. Customer focused, Darren supports clients to optimise their use of the RIM system and provides “fit for purpose” solutions to the client’s constantly evolving requirements.

 

LinkedIn Profile

 

 

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Senior Project Manager & Data Migration Lead

Stephan Picard, PhD

For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) projects and complex data migrations. With both technical and business expertise, he has assisted numerous clients with XEVMPD and IDMP implementations, also working with Calyx RIM Product Management as a subject matter expert.
CALYX-20-Headshots-JuliaMufel-FINAL

Business Analyst, RIM Product Management

Julia Mufel

As a RIM Product Owner, Julia works closely with Calyx’s Engineering and Regulatory Consultants teams to implement IDMP features within Calyx RIM, leveraging her extensive Article 57 experience capturing data and managing XEVMPD submissions. Her expertise includes Registration Planning & Tracking and Product Detail Management, with a focus on XEVMPD and IDMP.

 

LinkedIn Profile

 

 

今天就安排与凯理斯监管顾问的会面吧

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