The Blockstart Training Programme for Healthcare Manufacturers:

Blockchain-based data security and regulation of digital health devices

The mission of the Interreg NWE Blockstart project is to increase awareness and understanding of how blockchain technologies will impact the business of SMEs from the healthcare, agrofood, logistic and supply chain sectors. To do so, Blockstart launched a Free Training Programme where SMEs can select from a wide range of training units and discover the potential impact of blockchain with the support of the Blockstart partners and our network of transnational experts!

This webinar is especially dedicated to the needs of SMEs from the healthcare sector focusing on challenges of drug security and traceability as well as the regulation of digital health devices. If you have questions, feel free to contact the Blockstart consortium.

AGENDA

14.00– 14.10 Welcome & Blockstart Training Programme Introduction 

14.10 – 14.30 Blockchain in data security and traceability of essential drugs 

Anca PETRE, CEO, 23 Consulting, Paris Region 

• What are the key success factors in building a blockchain solution in healthcare?
• Can blockchain solve data security and privacy concerns?
  (Examples in the medical device industry)
• Is blockchain the most appropriate tool to track health products?
  (Lessons learned from a large-scale project) 

14.30 – 14.50 Medical Device Regulation of Digital Health Devices  

Christoph Kiesselbach, Schrack & Partner, Baden-Württemberg

• What is a medical/digital health device?
• Short introduction to the German Digital Health Applications Ordinance (DiGAV)
• How COVID-19 affects medical device development and regulation

14.50 – 15.00 Q&A 

SPEAKERS

Anca Petre is the CEO of 23 Consulting, a Paris-based firm whose mission is to support healthcare organisations in building digital solutions responding to patients' needs. One of the most common worries among patients today is the security and privacy of their data. Blockchain has, therefore, become one of 23 Consulting’s areas of expertise. Anca Petre is a pharmacist with 5 years’ experience in digital technology and healthcare. She is also the owner of MedShae Studio, a healthcare media and brand content company focused on podcasts.

Christoph Kiesselbach is a partner at Schrack & Partner offering consultation services and training with regard to medical device conformity assessment, certification and quality management. After graduating from the Free University of Berlin, he worked in the preclinical and regulatory context of medicinal products before changing to medical devices. Christoph Kiesselbach is a biologist with experience in medical device and medicinal product regulatory affairs and quality management. Priorities are next to the structure of quality management systems, the practical implementation of applicable legal requirements and standards for the development of medical devices and manufacturing processes.