eRA 2019 Speakers

Klavs Esbjerg, Epista Life Science

Klavs is CEO of Epista Life Science, a consultancy dedicated to continuously improving regulatory compliance. With offices in Denmark and Sweden, and 130+ global clients, Epista’s goal is to turn compliance obstacles into real business opportunities that add value to Life Science companies. How can that be done? Epista pioneers new compliance methodologies, bridges the gap between IT, Quality, and Line-of-Business departments, and benchmarks regulatory compliance – both for their clients, as well as the industry as a whole. The result: Quality organizations that are transparent, predictable and efficient – and that enable Life Science companies to reach their business goals.

Remco Munnik, ASPHALION

Remco is Regulatory Information Director at Asphalion S.L. in Barcelona and has a Bachelor degree in a study of Management, Economics & Law. He has over fifteen years’ experience in Global submission procedures, electronic submission and regulatory data management. 

Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich and Amsterdam. Within Asphalion, Remco is responsible for all global eSubmission projects (eCTD, NeeS, RIM, xEVMPD and ISO IDMP). His team is working on a both initial and maintenance submissions for all regions that accept eCTD. In addition a dedicated team is focussed on xEVMPD submission and IDMP implementation. 

In addition he is the chairman of Medicines for Europe Telematics working group and in direct contact with EMA and NCAs for the eSubmission roadmap, eCTD specification, validation criteria, eAF, CESP, Gateway, xEVMPD and ISO IDMP.

Sophia Vraka, Bavarian Nordic

Sophia has started her career as a Chemical Lab assistant in one of the pharmaceutical industries in Switzerland and continued her way out of the lab as a Regulatory Affairs Manager at SANDOZ GmbH where she was responsible for registrations in Europe.

After 6 years working for EXTEDO as a Business Consultant in various areas, she decided for a new challenge at Bavarian Nordic a pharmaceutical company which focuses on developing products to address cancer and infectious diseases. Working as an eSubmission Specialist, she has an overall responsibility for the preparation and submission of electronic regulatory filings (eCTD) in compliance with global health authority requirements such as the FDA, Health Canada and EMA.

Christian Kravogel, EXTEDO

Chris is Managing Consultant at EXTEDO and delegate for Switzerland at the ISO TC 215 Health Informatics. As member of the IDMP expert group at ISO he influenced the IDMP 2017 standard and it’s representation in SPL. As expert for IDMP and XEVMPD he supports companies in the implementation and use of XEVMPD and IDMP to ensure effortless Art. 57 compliance.  

Sylvie Colin, independent consultant

Sylvie started working in the Pharmaceutical Industry more than 15 years ago as an Executive Assistant in Pharmaceutical Marketing and Clinical Studies at FDM Pharma, Sophia-Antipolis, France (1993) and later Genactis, Vallauris, France (2000). Since then she has progressed to varied positions, such as Testing Clinical Trials Software for Fujisawa, Munich, Germany (2002), Price & Reimbursement Assistant at Allergan EU Research and Development, Sophia Antipolis, France (2003).

7 years ago, Sylvie was granted the opportunity to train on EXTEDO eCTDmanager software in order to start handling the publishing of regulatory submission dossiers. Since then, she has held positions as Regulatory Affairs Assistant and Publishing Specialist at Eudrac, Biot, France (2012) and later at Galderma Research & Development, Sophia-Antipolis, France (2013). In 2016, she was hired by Blue-Reg, Sophia-Antipolis, France as a Regulatory & Publishing Associate and quickly became a Publishing Manager. In January 2019, Sylvie decided to become an independent consultant to devote herself entirely to Publishing, Document Compliance and eSubmission activities.

Sylvie was born in New-York and has a dual French / American nationality.

Anjana Pindoria, EXTEDO

Anjana has experience in Regulatory and Technology, which ranges from writing MAA applications, Implementation of eCTD; XEVMPD, and multiple company integration of global product acquisitions. She is member of the IWG for xEVMPD and the Substance Subgroup for the ISO IDMP Taskforce. Anjana's passion and curiosity towards the merger of science and technology has enabled her to grow her knowledge within a short space of time. Her impatience and urge to make a difference soon brought her to EXTEDO. In 2016 she started working within EXTEDO's Product Management Team. Her role enables her to listen to the industry pains as well as scanning the horizon for future changes that could impact the way we work today.