About the video

Video recording from Day 3 Be The Expert 2022 virtual conference featuring:

1. Danijel Saifert, Amplexor Life Sciences: The impact of SaaS on the Pharmaceutical industry – to Cloud or not to Cloud?

2. Thierry Dietrich, Pharm@dviser: Ensuring data integrity and computerized system validation in the cloud

3. Vanja Primorac, Amplexor Life Sciences: Grab your business by the KPIs!

About the speakers

Danijel Saifert is Senior Manager for Strategic Accounts in Amplexor Lifescience. He is the holder of numerous technical certificates and scientific papers

on the topic of distribution computer systems and cloud. He has more than 10 years of experience in Managed services and Cloud infrastructure and SaaS, PaaS and IaaS.

He has built his career in companies such as ATOS and Samsung.

Dr. Thierry Dietrich serves in leading and consulting positions within the pharmaceutical and medical devices industries for more than 20 years. He founded pharm@dviser in 2016, and acts as management consultant.

His areas of focus are data integrity auditing, auditing of IT suppliers and IT organizations, leading of large IT projects in GxP regulated areas, validation of computerized systems, as well as the building and optimization of quality management systems with focus on IT and data quality.

Thierry Dietrich was/is leader resp. member of several GAMP® SIGs and ISPE. He also is the author of numerous technical publications, co-author on data integrity related books, and speaker on technical conferences. He received his PhD in natural sciences and master degree in chemistry from Johann Wolfgang Goethe University Frankfurt.

As a Life Sciences Consultant, Vanja is responsible for the contribution to the development and enhancement of the Amplexor Life Sciences Suite, as well as the provision of business process and data management expertise to Amplexor clients in the area of Quality Assurance.

Before joining Amplexor, Vanja worked in GlaxoSmithKline, where she was holding the position of Senior Quality Executive and Responsible Person.

About the video

Video recording from Day 2 Be The Expert 2022 virtual conference featuring:

1. Tris Nockels, IRSS Forum/Navitas: The future of labeling – a digital reality?

2. Remco Munnik/Dennis Verhaegh, IPERION: Streamline IDMP data in your RIMs to accelerate your eSubmissions and labeling

3. Renato Rjavec, Amplexor Life Sciences: Electronic submissions in the data-driven regulatory operations

About the speakers

Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products. She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
Remco is also an active member of EMA ISO IDMP Task Force Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. One of Iperion’s widely-acknowledged strengths is its deep networking with stakeholders across life sciences – including regulators, software vendors and customer groups.

As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

About the video

Video recording from Day 1 Be The Expert 2022 virtual conference featuring:

1. Kelly Hnat, K2 Consulting: Preparing for IDMP in times of uncertainty: What now?
2. Steve Gens, Gens and Associates: Industry RIM status: How are companies evolving and investing in the near and longer term?
3. Agnes Cwienczek, Amplexor Life Sciences: The Impact of IDMP on Regulatory Information Management

About the speakers

Kelly Hnat is a leader in RIM and IDMP with over 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations.  Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub team, and the SPOR EU Implementation Guide Focus Groups.  Additionally, she is a member of ISO TC215/WG6, is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards.  Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. 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 of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.

Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. 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.