5-7 June 2019
Dolce Fregate Provence
Saint-Cyr-sur-Mer, France




Frits Stulp
Iperion, Managing Director

Frits Stulp is Managing Director of Iperion Life Sciences Consultancy and IDMP SME. He has 18+ years of experience within the Life sciences industry. As a project manager he is specialized in management of IT projects for Regulatory Compliance, and has been the Program Manager of the first completed IDMP implementation program. Frits supports several clients as IDMP program advisor. Frits been a member of the EMA ISO IDMP Task Force and is an active speaker on IDMP on conferences and webinars.


Dr. Michel Mikhail
International Expert in Global Regulatory Affairs

Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generics industry. As a user and head of Global Regulatory Affairs, he selected, introduced, implemented, and rolled-out on worldwide level the RIM as well as the eCTD tools leading to modernizing the Regulatory Affairs function and beyond all related functions withjin the company frendering the company smart. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr. Mikhail served as a member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).


Ruud Veltenaar
Ruud Veltenaar & Associates, TEDx Speaker

Ruud Veltenaar studied philosophy at the Sorbonne University and Columbia University in NYC and International Business Management at Harvard. His vision, insights and humorous anecdotes are based on more than 25 years of experience as an entrepreneur and director at companies like McKinsey in the US, Volmac, RAET, Wegener and Planet Internet.

Speakers / Moderators


Tara Baer
PRA Health Sciences, Sr. Director

For more than 20 years, Tara Baer has worked within the pharmaceutical and medical device industry including AbbVie, Boston Scientific, Wyeth and Hoechst/Intervet. She began her career in Regulatory Affairs, then transitioned to Quality Assurance, Supply Chain/Artwork and Labeling. These moves increased Tara’s exposure to end-to-end labeling and fueled her passion for the process. In 2011 Tara founded Leaders in Labeling, a LinkedIn group of thought leaders in labeling for regulated products (Pharmaceutical, Biologics and Medical Devices). Today Tara leads the PRA global labeling team, acknowledging the value in providing labeling as a quality service to the Pharma and Device industries, supporting global patient safety and labeling development.


Jan Benedictus

Jan Benedictus, MSc, is the CEO of Fonto Group. With a background in life sciences, Jan has worked in online publishing and IT for most of his career. Fonto Group is the worldwide market-leader in solutions for user-friendly structured content authoring, with Fonto Editor as the flagship-product. From his experience within and outside the pharmaceutical industry, Jan will discuss trends and success factors in the adoption of structured content authoring by subject matter experts.


Julio Bonis
AMPLEXOR, Content Intelligence Senior Engineer

Julio Bonis is a Senior Engineer in the Content Intelligence team of AMPLEXOR. He is a medical doctor, software developer and epidemiologist. Julio's past experiences included working in positions related to clinical practice, bioinformatics research, Medical Affairs in the pharmaceutical industry, and more than five years in the Spanish Medicines Agency - involved in the development of Real World Evidence systems for Pharmacosurveillance and Health Economics & Outcome Research. In the context of those projects, he has accumulated more than 10 years of hands-on experience in the extraction of knowledge from unstructured data sources such as electronic health care records, patient complaints, biomedical literature or drug labelling documents by the use of Machine Learning and Natural Language Processing techniques.


Romuald Braun
AMPLEXOR Life Sciences, Vice President of Strategy

Currently the Vice President of Strategy at AMPLEXOR Life Sciences, Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.


Steve Gens
Gens and Associates, Managing Director

Steve Gens (MSOD) is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he lead global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He is a frequent speaker and was named to the 2017 PharmaVoice 100 for his contributions to industry.


David Gwyn
AMPLEXOR Life Sciences, Global Solution Architect

With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience delivering solutions to clients, with a particular focus in the areas of content management and collaboration. As a global solution architect for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer. David also leads the DIA EDM Submission Reference Model team, which has developed a document architecture for use when designing and building content management solutions. This architecture has been leveraged by numerous companies and vendors to provide submission management solutions that are compliant with global regulations.


Moncef Kafi
Guerbet, Head of Regulatory Compliance

Moncef Kafi is a PhD Pharmacist with six years’ experience working in Regulatory information management and regulatory compliance - for both consulting and Pharma companies. He has worked on several projects related to RIM implementation and is an IRISS member. Moncelf is recognized as a subject matter expert of RIM, and has presented at several RIM conferences.


Grzegorz Kojro
Pfizer, CDM Senior Specialist

Before starting a work in Pfizer, Grzegorz Kojro worked for six years as a Senior Regulatory Affairs Specialist for Valeant Pharmaceuticals. One from his main responsibilities were RIM system implementation. After a successful career helping with implementation and maintaining RIM system and also keeping and maintaining marketing authorization for medicinal products across EU and across different procedures, Grzegorz started work in Pfizer as Centralized Data Management Senior Specialist. This role works within a team whose main focus is to interpret regulatory data received across different geographies, functions, divisions and ensuring key activities and regulatory systems updates are completed while adhering to all policies, practices and procedures. Grzegorz is CDM subject matter expert responsible for big part of AFME countries and centralized procedure.


Ben Jacoby, PhD
Sensus Group, Ltd, Regulatory Consultant

Ben Jacoby PhD,  is an experienced regulatory consultant who has worked with clients in the diagnostic, medical device and pharmaceutical industries to help them bring innovative products to market. He provides regulatory and strategic guidance on EU and US issues to clients, with recent regards to the new EU MDR & IVDR ‘gold standards’ and how best to support multi-national and SME companies throughout the transition.


Ben Jaggers
Sensus Group Ltd, Chief Operating Officer and Co-founder

Ben Jaggers bring more than 20 years' experience within the commercial resourcing space and is an active member of many network groups specific to the medical device and in-vitro diagnostic industries speaking at events, actively involved in webinars and helping to spread the news on the importance of EU MDR and EU IVDR compliance.


Yvonne Middlefell, RAC, FRAPS
Stellar Regulatory Affairs Consulting, Executive Director

Yvonne Middlefell provides global regulatory affairs (RA) consulting, training and education for the IVD and Medical Device Sector. Yvonne holds a 2:1 Hons degree in Science, Technology and Management from the Open University. She is a fellow of RAPS and is also RA certified (USA). She has more than 29 years of Global RA experience, having held positions as an Executive Director of Global QA/ RA and Director Global RA. With extensive knowledge gained during a 10-year period when she worked in the USA.  She has worked for a number of key multinational corporations. These include Amersham Nycomed, Eastman Kodak, Bausch & Lomb and Johnson & Johnson. She has held a board positions and has set up QA/ RA functions for start-up companies. 


Heather Reilly
Janssen Inc., Director, Integrated Quality Systems Platform Lead, Quality Analytics

Currently the Director of Quality Analytics with Janssen, the Pharmaceutical company of Johnson and Johnson, Heather Reilly has an exceptional and diverse 20+ year career in the pharmaceuticals, consumer and medical device industries. Masterfully skilled professional in Good Manufacturing Practice (GMP), Verification and Validation (V&V), Good Laboratory Practice (GLP), Computer System Validation, HIPPA, Safe Harbor, SOX, ITIL and ISO 13485, she leads a global team in the Janssen Research and Development (R&D). Her vision is to transform data into risk-based insights and harness innovative tools and to deliver proactive quality, while driving top compliance. This is done by blending her passion, knowledge of science and ingenuity to profoundly change the trajectory of health for humanity. Her previous Johnson & Johnson roles have spanned a vast and diverse organization over the past 18 years. Prior to joining J&J she has worked in quality organizations at other Fortune 500 companies. She holds a bachelor’s degree in Chemistry from Rutgers University and a Master of Science in Quality Systems Management from the National Graduate School of Quality Management.


Orin Solomon
Norgine, Director, Senior Global Category Manager

Orin Solomon is currently Senior Global Category Manager at Norgine, a European specialist pharma firm. He has run his own Media production company; managed procurement teams in the Financial Services and construction industry and was the onsite buyer for the building of the Aquatics in the London 2012 Olympics. He is a subject matter expert and trainer of stakeholder management at Norgine and thrives on positive conflict resolution. Orin holds a second degree black belt, teaches kung fu and is an enthusiastic dad and husband.


Christian Lolk Thomsen
LEO Pharma, Project Manager

Christian is the Project Manager in Global Regulatory Affairs. He has a master of science in Engineering from Aalborg University in Operations and Management Engineering. A key driver is working in new ways and applying new technologies to drive effectiveness and efficiency. His career started as a student assistant in Global Regulatory Affairs at LEO Pharma A/S, then Application specialist in the systems team working with Regulatory Information Management System and now as project manager working with business projects in Global Regulatory Affairs. In the current project Christian is responsible for all Regulatory RPA development.


Alexander Tryba
Main 5, Director, Managing Director

As Managing Director and Partner, Alexander Tryba now has personal responsibility for the commercial expansion and development of MAIN5. For selected customers and topics, he acts as consultant on issues of digitization, quality, and compliance. While under the brand, ALTRA Consulting, Tryba advised leading pharmaceutical companies and when required, took on corporate management responsibilities as an interim manager. Until 2006, he served as Managing Director and Partner for the “neeb & partner” consulting firm. Tryba’s organizational focus was on the digitization of business processes, multisystem information management, and adherence to compliance requirements within the enterprise. He successfully bid for a variety of business-critical projects with leading medium-sized and large (DAX-listed) companies, ensuring effective guidance and successful outcomes in cooperation with his team. As Quality Management Representative (QMR), he was responsible at neeb and partner for projects, including the introduction and development of an ISO 9001-certified quality management system within the business.


Hans van Bruggen
Qdossier and eCTDconsultancy, Owner and Regulatory Scientist

Hans van Bruggen is CEO and Senior Regulatory Affairs Scientist at Qdossier. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients (and healthy volunteers). Using that scientific background he approaches interdisciplinary and international processes.

  • MDM and Reference data management
  • Managing regulatory information
  • Lean authoring of regulatory documents
  • Lean data, document- and dossier management

Once these processes are in place, commercial profits will be obtained as a bonus, rather than a goal in itself. Proper regulatory databases, document- and dossier management saves the pharmaceutical industry and agency time and money, leaving them to focus on their core business; namely: Public Health.


Monika Vytiskova
AMPLEXOR Life Sciences, Global Solution Architect

Monika Vytiskova is a Global Solutions Architect at AMPLEXOR with more than 11 years of experience in the Life Sciences localization industry. She provides innovative solutions driven by technology, AI and content intelligence for medical device and pharmaceutical customers’ labeling translation programs. Previously as program manager, she led a global retrospective labeling compliance program for a top pharmaceutical company, providing deep insight into the end-to-end labeling process for all global markets and the challenges around quality control and content management. She provides strategic management for AMPLEXOR customers exploring solutions in areas, such as regulatory intelligence or machine translation. Monika’s expertise is in practical applications of AI automation for language services that drive positive ROIs for customers.

Solution Day Presenters


Renato Rjavec 
Director of Products, AMPLEXOR Life Sciences

As Director of Products, Renato is responsible for AMPLEXOR’s Life Sciences Product Management. He has thirteen years of experience in analyzing, designing and implementing end-to-end regulatory solutions for the Life Sciences industry. In his first nine years at AMPLEXOR, Renato managed several implementations of integral regulatory and quality management solutions for global pharmaceutical companies as well as health authorities. Over the past four years, Renato established the Product Management organization that focuses on innovation, compliance, and quality of its product portfolio. Renato has a bachelor’s degree in Computer and Information Science from Ljubljana University.


Agnes Cwienczek
Senior Life Sciences Consultant and Team Lead, AMPLEXOR

Agnes has been in the position of Senior Life Sciences Consultant for AMPLEXOR since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the AMPLEXOR Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to AMPLEXOR clients in Regulatory Information Management, Document Management, and Submission Management.

Before joining AMPLEXOR, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization. She was responsible for implementing and maintaining the regulatory applications and data management strategy and roadmap, and ensure business operation of applications under her responsibility, and to lead a global team of regulatory operations experts. Agnes received her master’s degree in Information Management from the University of Koblenz-Landau.

Siniša Belina

Siniša Belina
Senior Life Sciences Consultant, AMPLEXOR

Siniša is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to AMPLEXOR in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.


Karmen Umek Luzar
Principal Product Consultant and Team Lead, AMPLEXOR Life Sciences

Karmen has been part of AMPLEXOR’s Product Management team for the past three years. Her responsibilities include team leadership and development of RIMExpert, SubmissionExpert, and R&DExpert solutions. Karmen’s extensive background at AMPLEXOR dates to 2001. Before joining Product Management team, Karmen worked as either Consultant or Project Manager in regulatory solution implementations for numerous pharmaceutical clients which has brought her an in-depth knowledge of electronic records and submission management. Karmen received her master’s degree in Information Management from the University of Ljubljana.


Jelena Milićević
Product Consultant, AMPLEXOR Life Sciences

After a robust career in managing cutting-edge technology projects within the world of ERP and BI, Jelena joined AMPLEXOR as a Product Management Consultant for the Life Sciences Suite three years ago. Being passionate about innovations and new approaches to the methods of operations, she closely cooperates with both clients and internal experts on presales activities and proof of concept projects in the pharmaceutical industry. Jelena is a Graduate Engineer in Organisational Sciences, holding a BSc (Hons) degree in Quality Management in Information Systems from the University of Belgrade and a diploma from Moscow State Institute of International Relations.


Judit Virgula
Life Sciences Consultant, AMPLEXOR

As Life Sciences Consultant, Judit is responsible for ensuring regulatory compliance of the RIM and Submission solutions. She also supports implementation projects through solution trainings and workshops. She has fifteen years of experience in the pharmaceutical industry in the R&D and Regulatory Affairs field. Judit received her Master of Science (MSc) degree in Chemical Engineering, specializing in the pharmaceutical industry from the Technical University of Budapest.


Sonja Popovac Zavodnik
Senior Product Consultant and Team Lead, AMPLEXOR Life Sciences

Sonja works in Product Management at AMPLEXOR Life Sciences and leads a team responsible for developing the VigilanceExpert and ProductExpert modules. In previous positions, she worked as a Business Analyst and Project Manager on business process automation projects for core and industry-specific business process in the Financial industry, telecommunication, customs, and logistics. Sonja received both her bachelor’s degree in Mathematics and master’s degree in Computer and Information Science from the University of Ljubljana.


Anamarija Doležal
Senior Product Consultant, AMPLEXOR Life Sciences

Anamarija joined AMPLEXOR’s Product Management team in the beginning of 2019. Her responsibilities include analyzing and designing end-to-end regulatory solutions for the Life Sciences industry, primarily focusing on RIMExpert, SubmissionExpert, and R&DExpert solutions. Before that, she was working for twelve years as a Consultant or Project Manager in the implementation of regulatory solutions for many pharmaceutical clients, where she gained knowledge of regulatory processes and procedures. Anamarija received her master’s degrees in Biotechnology and Nutrition from Zagreb University.


Sebastian Ladika
Product Consultant, AMPLEXOR Life Sciences

Sebastian Ladika joined AMPLEXOR’s Product Management team as an analytics specialist and is responsible for the development of analytics capabilities for the Life Sciences Suite. Sebastian comes to AMPLEXOR with extensive experience, having served as data management consultant building DWH/BI solutions for large multinational banking and telecommunications clients. Sebastian Ladika received a master's degree in computer sciences from University of Zagreb, Faculty of Electrical Engineering and Computing and a post master's degree in economics from University of Zagreb, Faculty of Economics & Business.