eRA 2017 Speakers

Vada A. Perkins MSC, MS, DrSc (c), Identifica LLC.

Vada A. Perkins is the Managing Principal of IDENTIFICA LLC, an independent global regulatory intelligence and life sciences solutions practice.

Before starting IDENTIFICA, Vada began his career as a regulatory reviewer/project manager at the U.S. FDA and retired from uniformed service in 2016  as a Senior Advisor for Regulatory Science/Acting Deputy Associate Director for Regulatory Review Management.  Vada worked closely with senior leadership on a broad range of regulatory and policy issues in the development, interpretation, and implementation of guidance, regulations, and international data standards (e.g., ISO IDMP, HL7 SPL, eCTD/RPS, ICSR, UDI) to support the comprehensive review of drugs, biologics, and devices throughout the product lifecycle. 

He is a recognized international expert for ISO IDMP  as a topic leader for ISO Technical Committee 215/Working Group 6-Health Informatics and serves as lead editor for 5 ISO IDMP related documents.  He received his degrees from The Johns Hopkins University and the University of Southern California.

Steve Gens, Gens and Associates Inc.

Steve is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategy and transition roadmap development, regulatory information management, industry benchmarking and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then moved into consulting to grow and lead several global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership which are regularly cited in publications and conference presentations.

Karin Gröndahl, Medical Products Agency, Sweden

Karin has been working at the MPA since 1988 at the biological and biotechnology laboratory, as a pharmaceutical assessor for biotechnological medicinal products and as Head of Registration and Information Management. The current position is focused on IT related business development and strategy. Karin has been responsible for the implementation of eCTD and electronic-only submissions at the MPA. She has also been involved in this work on EU level with for example eCTD M1 specifications, validation criteria, technical guidance and the eSubmission Roadmap and is currently member of the eSubmission CMB, the Human Harmonisation Maintenance Group and the CESSP project team. 

Michael Zhang, Pfizer (China) R&D Center

Michael is team manager for APAC Submissions Management Hub in Pfizer (China) R&D Center. APAC Hub, as part of Pfizer Worldwide Regulatory Operations, is providing industry-leading dossier execution and consultation service across Pfizer APAC markets. Michael holds Master of Science degree in regulatory affairs from Northeastern University. He has over 8 years in eCTD/NeES and other format of submission publishing experience for major markets like US/EU/JP/ANZ etc., and has over 5 years in submission management from dossier planning to archive for APAC markets like China, Korea, ASEAN and ANZ.

Heinz Knöpfli, Swissmedic

Heinz is Head of Innovation Management at Swissmedic. Together with his team he is responsible for the implementation of Swissmedic's IT Roadmap. In addition he ​is the project leader for the Swissmedic Portal solution that enables the transmission of th​e pharmacuetical​ industr​y​'s application​s​ directly ​to the Swissmedic Backend-Systems (EURS and DMS).

Heinz has worked for more than 30 years in the software industry starting as a software developer. As head of project management and ​as a ​project leader, he ​has ​led a variety of systems into production for various industries such as healthcare, telecommunications and finance. Heinz holds a degree in Business Information Technology.

Remco Munnik, ASPHALION

Remco is Regulatory Information Director and has over 15 years experience in global submission procedures, electronic submission and regulatory data management. Within Asphalion, Remco is responsible for global eSubmission projects (eCTD, NeeS, RIM, xEVMPD and ISO IDMP).

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.

Ulrich Plener, Merck KGaA

Ulrich studied business informatics and wrote his thesis on eCTDs because of his interest in XML. He worked four years in Regulatory Operations at Altana Pharma (now Takeda), before joining Merck. After participating or leading projects in the area of Document-, Submission- and Regulatory Information Management as a “Business Partner Biopharma Global Regulatory Affairs and R&D Quality” he now connects Group Business Technology with Biopharma R&D.

Karl-Heinz Loebel, Pharmalex

Karl-Heinz studied Chemistry at Heidelberg University, Germany. After some time in Biotech industry, he changed to regulatory Affairs in 2005. For the last twelve years his professional career has developed around electronic submissions. He currently holds the position of Director Principle Consultant Regulatory Operations at PHARMALEX, a service provider in the areas of Development Consulting, Scientific Affairs, Regulatory Affairs and Pharmacovigilance for pharmaceutical industry. His expertise comprises eCTD and non-eCTD submissions worldwide as well as XEVMPD and IDMP. He is a continuous speaker and presenter at various German and international conferences, workshop and training courses on electronic submissions. 

Qingling Lian, Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.

Qingling is the supervisor of the Regulatory Affairs department at Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd., a subsidiary of Qilu Pharmaceutical group in China. The company focusses on API manufacturing including penems, cephalosporin, anti-cancer and common drugs. Qingling is responsible for the registration of these APIs globally.  At this time, the Qilu team has successfully submitted USDMFs to the FDA, ASMFs for CEP and the EU, MFs in Japan and DMFs in PDF and NeeS formats to other countries such as Canada, Mexico, Korea. In cooperation with EXTEDO, they are currently converting their legacy submission formats to eCTD. It is a challenge but also a chance to make further significant improvements to their competitiveness in registrations. 

Joann Tien, ACADIA Pharmaceuticals

Joann leads the implementation, validation and training efforts for global RIM systems for both pharma & medical devices at ACADIA in San Diego, CA, USA.  Currently she is the project coordinator and analyst for integrating an in house publishing system (EXTEDO eCTDmanager) with an eDMS (Veeva Vault).

Ruedi F. Blattmann, Life Sciences Consulting Partners

Ruedi is Managing Partner of LSCP Life Sciences Consulting Partners, global network of currently 65 experts in the EU, US, Japan and China. Main focus is Enterprise Regulated Information Management based on globally applied Standards (IDMP+, eCTD and beyond). Ruedi works in this domain for over 30 years.

Dr. Leonardo Ebeling, Dr. Ebeling & Assoc. GmbH

Dr. Leonardo Ebeling, Managing Director and co-founder of Dr. Ebeling & Assoc. GmbH, has more than 25 years of experience in Drug Safety and Medical/Regulatory Affairs. He completed his studies in human medicine at the University of Hamburg and joined the pharmaceutical industry shortly after to develop his career in Pharmacovigilance, Medical and Regulatory Affairs and Drug Development. Due to his various senior positions as Medical Director and Managing Director in Medicine, where he has gained broad experience in all aspects of Drug Safety, he has an in-depth understanding of global regulations and guidelines.

Kieran O'Donnell, TMC Pharma

Currently representing TMC Pharma as VP Pharmacovigilance and QPPV, Kieran has ~18 years of industry experience in pharmaceutical companies; CROs and PV consultancy. Since 2006, Kieran has led European and Global PV operations, gaining broad experience in PV QMS; Benefit-risk management; Signal Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; and Inspections (MHRA & FDA). Kieran was part of the ABPI PV Expert Network, and currently sits on the RQA PV Committee, and is a fellow of PIPA.

Sean Neal, Medidata Solutions

Sean has been working with Safety processing and Clinical Trials for the past 15 years.  He has a strong background in Project Management and Technology for most of his 25-year career. The past 10 years Sean has focused on Safety Gateway and EDC in Clinical Trials at Medidata Solutions.  He has spoken at many conferences over the years as a subject matter expert on EDC data to Safety systems.

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.  

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. 

Rasmus Torp Kristensen, Epista Life Science

Rasmus is Senior Consultant and team manager at Epista Life Science. He holds a degree in Production Engineering from Technical University of Denmark. Since 2010 Rasmus has been working with Life Science clients in a number of different projects primarily covering Project Management, IT-validation and automation. Rasmus is responsible for Epista’ ECM (Enterprise Content Management) area focusing on improving the quality and governance of regulatory data and content our clients.

Matthias Krautheim, OpenText

Matthias started his professional career as Validation Manager i.e. responsible for software quality, testing, and documentation at a research driven pharma company. He broadened his skills in the fields of internal business process consulting and harmonization, especially in the medicinal and regulatory environment of the pharmaceutical industry.

Today Matthias supports customers of the life sciences industry in global implementation projects, project management, process management and change management around submission content management projects.

Michael Menges, Werum IT Solutions

Michael is Head of eBusiness Solutions at Werum IT Solutions GmbH. Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Working for Werum since 1999, Michael has more than 17 years of experience in the field of software development and IT projects in the pharmaceutical industry. In his role as product manager at Werum he is responsible for the development of the RImanager product and the project implementation.  

Cristina Luna Alabate

Cristina is National Regulatory Affairs Manager in Kern Pharma, a diversified laboratory reference in generic medicinal products in Spain. She started working in Regulatory Affairs in 2006 and joined Kern Pharma in 2008. From 2014 she holds the position of National Regulatory Affairs Manager. She is responsible for all the regulatory activities related to the portfolio that Kern Pharma is marketing in Spain, the regulatory strategy for new medicinal products and also the pricing and reimbursement procedures.

From the position of Regulatory Affairs technician she acted as the contact person for all the issues related to IT that increased with the use of eCTD tools and eDMS. On the other hand, as responsible of the regulatory data of all the products marketed by Kern Pharma in Spain she was aware of the difficulties to manage of all this data. For all this, she was designed as the project leader for the implementation of Extedo tools in Kern Pharma.

 

 

Dr. Silke Nolkemper, EXTEDO

Silke has more than 7 years experience as Regulatory Affairs Manager in the pharmaceutical industry. After starting her career at PharmaLex, she joined Sandoz/HEXAL, where she was accountable for a broad sprectrum of marketing authorisations within EU, Asia Pacific, Latin America and Middle East as well as for some aspects of pharmacovigilance. At EXTEDO, Silke is responsible for the implementation of regulatory updates regarding eSubmission (eCTD, NeeS, eCopy, VNeeS, ASMF, DMF) as well as Planning & Tracking. She provides regulatory advice to both internal colleagues and external customers and she helds training courses.

Sophia Vraka, EXTEDO

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.

Sophia has joined EXTEDO 2012 and acts as Business Consultant in various areas like eSubmission, Software Training & Workshops, Computer System Validation as well as in supporting clients in regulatory topics.

Maren Müller, EXTEDO

Maren is Senior Business Consultant and responsible for consulting regarding eSubmission (eCTD, NeeS, eCopy, VNeeS, ASMF, DMF, …), additionally for answering support questions for regulatory topics and software trainings, speaker at conferences and leading industry and agency projects as IPMA certified project manager. Maren began her career as a Regulatory Affairs Manager at ALIUD Pharma GmbH where she was responsible for registrations in Eastern Europe and Germany for 3.5 years.

Christine Hirt, EXTEDO

Christine is Director of EXTEDO’s Regulatory Compentence Center and responsible for regulatory business consulting. She has more than 10 years of experience in the field of Regulatory Affairs and worked for serveral pharmaceutical companies, most recently 8 years as Head of Regulatory Affairs, before she joined EXTEDO. Christine is an expert for regulatory and eCTD/XEVMPD/IDMP guidelines and regulations and active member in several associations, such as DIN/ISO TC/WG6, BPI and MEGRA.

William Gardner-Mims, EXTEDO

William has more than 7 years’ experience implementing regulatory software systems in the pharmaceutical and life sciences industry. He began his career as a Regulatory Operations Publisher at Octagon Research Solutions (now Accenture), where he was responsible for performing electronic publishing and document compliance on electronic submission documents. He then joined the Software Implementation Services group, where he was accountable for a broad spectrum of software implementation activities, including process analysis, training, validation and ongoing support. William joined EXTEDO in 2015 as Business Consultant in the Professional Services – US department. In this role he is responsible for the implementation of EXTEDO’s eCTDmanager software, including training, project management, validation and installation.  In addition, he takes care of answering support questions for FDA regulatory topics. 

Klavs Esbjerg, Epista Life Science

Klavs is CEO of Epista Life Science, a consultancy dedicated to continuously improving regulatory compliance. Epista turns compliance obstacles into real enablers that help clients reach their business goals. Klavs holds a degree in Chemical Engineering from the Technical University of Denmark as well as a management degree from Scandinavian International Management Institute. Since 1997, Klavs Esbjerg has gained substantial industry experience as a Life Science consultant working on validation and project management. In 2009, Klavs co-founded Epista and is currently responsible for sales, delivery, personnel and the company’s expansion.

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