IDMP is becoming more and more reality, with the published EU implementation guides and the recent presentation of the DADI forms. EXTEDO and Iperion have joined forces to host a webinar giving the latest developments from EMA and the regulators and to navigate you through the regulatory landscape.
Why should you attend:
- Understand the impact of DADI on your IDMP project
- Have an overview of the challenges regarding your processes, organization, technology and information
- Learn from several use cases what the importance of IDMP implementation is within your organization
- Know how to take your management along this IDMP journey
Through the extensive consultation and managed services from IPERION and the advanced tooling and technology that EXTEDO offers, the webinar is the perfect starting point to excel with IDMP in the future.
- Current Status: ISO IDMP Implementation in Europe
- SPOR program: SMS/EU-SRS/G-SRS OMS and the connection to EudraGMDP
- Telematics landscape: DADI, ePI, eCTD 4.0, CTIS, lessons learned from COVID and its connection to mitigating shortages of medicines in the supply chain
- Future Promise and objectives
- The promise of TOM
- Data only submissions
- Mastering Medicinal Product Data
- Impact of ISO IDMP on Pharma
- Relevant Use Cases
Dennis Verhaegh is a Senior Consultant at Iperion - a Deloitte business. He has been working for 4 years in the Life Sciences and Regulatory Affairs industry, providing consultancy in IDMP / digital transformation projects at various clients. Additionally, as account lead, he also provided hands-on support in data maintenan ce and data remediation projects in Regulatory Information Management (RIM) systems. Additional experience in change control, labelling, xEVMPD, IDMP, and telematics has been gained through projects. Supporting the IRISS IDMP Topic Group.
While working for a medical device company, Dennis has gained some additional experience in the Medical Device Directive and Regulation
Iperion is a globally-operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.
Anjana has over 10 years of experience in the life science sector, she is currently working within Product Management at EXTEDO, where she is responsible for the management of the Industry and global health authority reviewing solution. She is also proactively leading numerous European Commission initiatives, that strives to achieve global standards for structured data, which will lead to better consumption of complex scientific information to patients and healthcare professionals by applying digital methods. Anjana's passion and curiosity towards the merger of science and technology has enabled her to grow her knowledge, all the while, enabling her to listen to the industry pains as well as scanning the horizon for future changes that could impact the way we work today.
Remco Munnik 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.
Event Details and Registration
Date: 14 June 2022 | 15:00h GMT (London, Lisbon) | 16:00h CEST (Berlin, Paris)
Duration: 60 Minutes | If the time does not fit you, register anyway and we will send you the link to the recording.
Participation is free of charge.