2021
Speakers

Agnes’ main responsibilities are the provision of business and compliance requirements for the Amplexor Life Sciences Suite. She also manages the Life Sciences Consultants in the delivery of process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, Submission Management and Labeling Management.

Chris is Swiss delegate at the ISO TC 215 Health Informatics and co-architect of the IDMP standard. After working for many years as xEVMPD and IDMP product manager and solution consultant for the software vendor EXTEDO, he changed 2020 to Galenica, one of the largest Health Care companies in Switzerland. At Galenica as well as member of the advisory board of the Swiss Refdata foundation, he is supporting the implementation of the IDMP standard in Switzerland..

With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President 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.

Frits Stulp is Managing Director of Iperion Life Sciences Consultancy, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved as EU-SRS project manager for Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. He is also member of the EMA ISO IDMP Task Force Substances & Products. Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

Hanno holds a Master's degree in Psychology and has more than 18 years of experience in the life science industry. After 15 years in management at a consulting firm, he moved into AI product development for pharma. At Averbis, he is the first point of contact for customers in the life science sector. He loves to add value.

Peter Brandstetter is a Technology Consulting Senior Manager with Accenture.  Peter has experience across the fields of IT in the life sciences industry, in particular the pharmaceutical sector.  His areas of specialization are quality management and quality assurance in manufacturing and R&D as well as enterprise content management.

As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry..

Siniša Belina 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.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science consulting and benchmarking firm specializing in strategic planning, regulatory information management (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 led global Life Science 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, has many publications, and was named to the 2017 PharmaVoice 100 and 2020 R&D Innovations for his contributions to industry.