Webinar: Regulatory Information Management: from R&D planning to XEVPRM and ISO IDMP

Sponsored by: INFOTEHNA

Focused on:

  • Pharma
  • Regulation
  • Documentation
  • Software

Date: 2 October

1877

Time: 3PM London / 10AM New York

Practical insight into the complex process of managing regulatory information in a global environment

In the present regulatory environment there is a tendency to switch every business process to an electronic format but it is often overlooked that electronic isn’t always better. Very frequently you can hear people talking about the good old paper times, when everything was easy. The most common reason for this sentiment is the use of non-integrated document and process management systems.

There is often one application for saving documents, other for tracking, third for reporting, and there may be other dedicated applications – for corrective actions-preventive actions (CAPA), change management, eCTD, and now for XEVPRM. The result is that although e-solutions are in place, everyday work is more complicated than before, and the working day comprises of logging in and out of different applications, searching for data and composing reports.

The only way how to avoid such mess is to plan in advance and integrate all of your data and process management in one system. Once data is gathered and available, formatting according to regulatory requirements becomes necessary. Based on eCTD and XEVPRM, this webinar will demonstrate how even the most complicated requirements can easily be handled with adequate software solutions. But it will also offer a look beyond that – to the future requirements such as ISO IDMP and how companies can prepare for it.

Join this webinar to get acquainted with the latest challenges in the regulatory environment and learn how software packages can help you ease the necessary workload.

Presented by

Sinisa Belina, MSc. Pharm. ,

Product development, Process improvement

Mr. Belina started his professional career in PLIVA (TEVA Group member), renowned for its highly competent employees, innovative technologies and continuous investments in production. In addition to his responsibilities in manufacturing, he was part of the very successful Electronic Document Management System (EDMS) implementation project.

In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Assistant Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.

In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Assistant Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.

Andrew Marr, PhD,

Managing Director, Marr Consultancy Limited

Dr Andrew Marr is currently Managing Director of Marr Consultancy Limited, founded in 2011, which specialises in consultancy on e-regulatory affairs for human medicines and currently focusing on XEVMPD.

Previously Andrew was Director of Global e-Regulatory Development in Global Regulatory Operations at GlaxoSmithKline R&D, based in the UK. He worked in Regulatory Affairs for 27 years in a variety of roles within GSK with responsibility for contributing the external regulatory input in to the design, implementation and the management and use of electronic document, labeling and submission publishing systems and processes throughout GlaxoSmithKline.

Andrew has been a lead and member of a number of industry and industry/agency committees in the information management field :

• Rapporteur for ICH M2 which includes the Individual Case Safety Report, Identification of Medicinal Products and the electronic Common Technical Document within its scope
• Member of EFPIA eCTD Topic Group
• Co-chair of the EMA/EFPIA Product Information Management (PIM) Project addressing the future of the electronic management of product information in the EU.
• EFPIA Topic Group Leader for PIM
• Ad hoc member of the Eudravigilance Working Party for the duration of the development of the new ICSR and IDMP standards
• Member of the EFPIA Telematics Working Group which drives the strategy for the electronic interface between industry and agency

Andrew is currently the IRISS Forum IDMP Topic Group Leader.

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Key Learning Objectives

  • Get familiar with the latest changes in eCTD regulations.
  • Learn how to manage post submission changes in eCTD
  • Find out how to implement Eudravigilance Medicinal Product Dictionary
  • Discover how to get all the reports you need, without once transcribing the data

Audience

  • CEO/President/Chairman/Executive Director
  • Professionals in Medical Writing
  • Regulatory Affairs
  • Dossier and Document Management
  • IT and Data Management
  • Compliance
  • Publishing and Submission Management.