About the webinar

Have 60 minutes to spare? Amplexor, together with DeviceTalks, hosts expert panelists, Ann Cramer, Director of Digital Product Delivery and Operations at LifeScan; Ilyssa Levins, Regulatory Process Advisor for Digital Health; and Anand Iyer, Chief Strategy Officer at Welldoc to dig into this topic! You’ll glean crucial knowledge from three key perspectives in the thick of digital transformation in life sciences.

About the speakers

Ann Cramer is Director of Digital Product Delivery and Operations at LifeScan, a global leader in glucose monitoring and diabetes management. She is a results-driven leader with over 20 years of experience leading technology teams, providing custom proprietary and commercial solutions. Ms. Cramer has over 10 years of experience in regulated software development and has a passion for technological innovation and creating solutions that are engaging and support improvement of patient outcomes. Outside the office, Ms. Cramer keeps busy with her 4 children and 2 dogs. When possible, she loves entertaining her close friends and travel with her family.

Ilyssa Levins founded the Center for Communication Compliance (CCC) to help pharmaceutical and medical device companies save time and money, while managing risk. A 35+ year industry veteran, Ilyssa understands how to achieve both business and regulatory objectives, and align compliance and marketing stakeholders. An award-winning futurist, and published author, Ilyssa is on the cutting edge of applying artificial intelligence and natural language processing to manage the explosion of content that requires rapid review and approval to support the commercial’s strategy of customer centricity. Ilyssa was named one of the industry’s 100 Inspiring People by PharmaVoice Magazine.

Anand Iyer is a respected global digital health leader—most known for his insights on and experience with technology, strategy and regulatory policy. Anand has been instrumental in Welldoc’s success and the development of BlueStar®, the first FDA-cleared mobile prescription therapy for adults with type 2 diabetes. Since joining Welldoc in 2008, he has held core leadership positions that included Chief Data Science Officer, President and Chief Operations Officer. In 2013, Anand was named “Maryland Healthcare Innovator of the Year” in the field of mobile health. As a founding member of the Digital Therapeutics Alliance in November 2017, Anand works closely with the board to engage industry leaders on the integration of clinically-validated digital therapeutics to improve population health.

About the webinar

Watch our webinar for tips on how to maintain quality, efficacy and safety of the products at hand.

In this session, you’ll learn about:

• The potential and opportunities of implementing integral quality management platforms
• How to merge them into the comprehensive process that includes R&D, manufacturing, regulatory and labeling
• How to manage process dependencies
• …and more

About the speakers

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.

(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.

About the webinar

Watch our webinar for tips on how to expand and improve your RIM system landscape.

In this session, you’ll learn about:

• The shift from a document approach to a data-centric approach
• Which system capabilities can be used for system transformation
• Practical examples, including a demonstration, on how to implement a transition
• …and more

About the speakers

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.

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About the webinar

Watch our webinar for a general status update on IDMP.

In this session, you’ll learn about:

• The data model updates
• The future of data submission
• How the current 3rd acknowledgment process will be addressed
• …and more

About the speakers

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.

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.

About the webinar

Find out more about best practices regarding the drug product lifecycle through content management, by prioritizing regulation and productivity.

In this session, you’ll learn:

• How to improve your decision making
• How to support the drug product lifecycle
• How to harmonize content and process mangement
• …and more

About the speaker

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.

About the speaker

As Managing Director and Partner, Alexander 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 businesscritical 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.