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.
Dr. Fakhredin Sayed Tabatabaei
Fakhredin Sayed Tabatabaei is a medical doctor and an epidemiologist. He works as a senior assessor at the pharmacovigilance department of the Dutch national agency (MEB) for more than 13 years. Since 2017, he is part of the ‘Better Use programme,’ initiated within the Dutch agency, focusing on improving access to product information, so that both patients and healthcare providers can search for, find, consult and use information about medicines.
Kontantin Koshechkin, Ministry of Health Russian Federation
Konstantin is a Head of Information Department in Scientific Center for Expertise of Medical Application Products Ministry of Health (Russian Federation).
His main field of expertise is overlap between IT and pharmacy. He have PhD in Biology as well as experience in IT field. During his career he led multiple projects to automate drug evaluation
and approval process in Russian Ministry of Health. The main areas of his work are the organization of software development, technical support, the organization of electronic interaction with regulatory authorities and other market participants.
Ted Hanebach, ICON
Ted Hanebach is Director of the Regulatory Operations department at Icon PLC. He and has led the team for over 18 years. During his tenure in Regulatory Affairs, he has developed expertise in document management and in various electronic standards, including eCTD, IDMP, SPL, RPS and CDISC standards.
He participated in Canadian TPD ESTRI and eCTD working groups, and in the work of IRISS eCTD Lifecycle and ETICS III groups (regional leader). His area of interest lies in the function of XML in regulatory standards, document management and data transfer.
Sylvie Colin, SYLV’eDOCS
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.
Dr. Reinhard Nibler, Nibler & Partner
Reinhard Nibler, born in 1967, studied medicine and economic- and social sciences at the universities of Munich and Hagen in Germany. He received his doctoral degree in medicine from the University of Munich in 1995.
After clinical education and service as a medical officer in the German armed forces, he received board certifications in anesthesia and medical quality management from the Bavarian state medical board in 1999. He is a TÜV Austria certified auditor for the pharmaceutical and health care area.
From 1998 until 2004 he held several positions at the German subsidiary of Schering-Plough, finally as manager clinical research and head of drug safety. Since 2004 he is working as consultant, specialized in implementing pharmacovigilance- and quality management systems for pharmaceutical and health-care enterprises and pharmacovigilance auditng. Dr. Nibler also serves as trainer and consultant for pharmacovigilance software for Extedo GmbH and acts as QPPV for multiple companies.
Dr. Nibler is former president of the Middle European Group for Regulatory Affairs (MEGRA), regular trainer for Forum Institute and course author Drug Safety at the Steinbeis University School GRC.
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.
Marta Gascon, PhD, Kern Pharma
Marta holds a PhD in Organic Chemistry from Universitat Autonòma de Barcelona and, afterwards, she moved to Belgium where she worked as a postdoctoral researcher in the KU Leuven.
In 2017, she joined the Regulatory Affairs department of Kern Pharma S.L. where her overall responsibility is the preparation of the CMC documentation for the maintenance of the dossiers and for new registrations.
She is taking care of eCTD tool and has been involved in the implementation of the RI-Manager database in the department.
Beatriz Domínguez, PhD, Kern Pharma
Beatriz holds a PhD in Organic Chemistry from Universitat Autonòma de Barcelona.
In 2015, she joined the Regulatory Affairs department of Kern Pharma S.L. where her overall responsibility is the preparation of the CMC documentation for the maintenance of the dossiers and for new registrations and the preparation and maintenance of the Active Substance Master File and Certificate of Suitability to the European Pharmacopoeia for the active substances manufactured in the Chemical Plant.
She has been involved in the implementation of the RImanager database in the department.
Gary Wilson, CorrIT
Gary is an experienced IT technical consultant and software team lead. Gary has lead international projects for both public and private sector clients in the areas of eSubmissions & Structured Data and is the creator of the SPORIFY web application to assist with the Implementation and Integration of Master Data & Controlled Vocabularies.
Kevin Horan, BearingPoint
Kevin Horan is currently a senior manager at BearingPoint, a management and technology consulting firm, focused on delivering services for the pharmaceutical industry. Before joining the BearingPoint Kevin was the Director of ICT & Business services at the HPRA in Ireland for 17 years and has been a member of various EU working parties defining standards for telematics systems. Prior to working at the HPRA he also held roles in the pharmaceutical industry in both manufacturing and distribution.
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.
Caius Stefan Giura, independent consultant
Since joining the pharmacovigilance field in 2013, Stefan hase coordinated a PV team in 4 locations, in 3 countries and 2 continents. His CRO experience covers working with over 50 MAHs and CROs as well as a network of PV vendors in all EU countries, from consultancy work to project implementation and management. During the course of his work, he has hosted an inspection and multiple audits, including managing the resulting CAPAs, implementation of procedural changes and training of employees, clients and vendors.
Having joined the CRO environment right after the 2012 changes, he created, implemented and maintained the entire post-marketing PV system of the company, updating it as needed following changes in client requirements, regulations and legislation.
For the future, Stefan is interested in expanding his expertise to cover all areas of PV and PV QA.
Catherine Rychihina, Ministry of Health Russian Federation
Catherine is a Head of the Control Department in Scientific Center for Expertise of Medical Application Products Ministry of Health (Russian Federation)
The main direction of work of Catherine is the organization of the drugs evaluation process in accordance with the legislation requirements. The most progressive projects of Catherine are the creation of a system for evaluating the drugs interchangeability, a system for testing pharmacopoeial articles and many others. And now she is engaged in the process of an electronic submission of the registration dossiers according to the rules of the Eurasian Economic Union.
Simon Li, Molecular Science Center (MSC), Genetics Generation Advancement Corp.
Simon Li is the senior manager at GGA Corp. in Taiwan. Leading a team in scientific informatics business. His main expertise is in pharmaceutical industry total solution, including ELN, LIMS, RIMS, QMS and MES. Participating in various projects in new drug development, material innovation, NGS analysis, and computational system validation.