Date(s) - 02/12/2019
12:30 pm - 5:30 pm PST
Westin San Diego
NAMSA’s complimentary IVD Clinical Research & Quality Systems Summit provides a unique opportunity for IVD organizations to learn directly from NAMSA’s team of experts. This small, intimate gathering will focus on the latest quality systems challenges surrounding IVDR and clinical research trends concerning IVD products. The event includes two sessions as well as a panel discussion. Cocktail reception to follow.
Highlighted during the event will be the following presentations:
Design of Clinical Plans for Global Registration
IVDs have global application and impact. Understanding strategies for designing clinical plans to achieve product clearance or registration in multiple regulatory jurisdictions is crucial to product commercialization. The clinical validation phase of product development is timely and expensive. Understanding common events, which may cause time delays and cost overruns, allow development of contingency plans to reduce and mitigate risks to the business plan.
This presentation will cover:
- Designing clinical plans for product submission in the US, EU and China.
- Acceptability of clinical evidence in the US, EU and China current and future.
- Managing clinical trial timelines and costs.
Establishing IVDR Compliance within your Quality Management System (QMS)
Understanding and effectively addressing the EU’s IVDR requirements associated with its Clinical, Quality and Regulatory impact, changes and post-market activities is necessary for alignment, governance and sustainability of your companies QMS.
This presentation will focus on:
- Impact of changes (Clinical, QMS, Device vigilance/surveillance)
- Elements required now prior to May 2022 (PMS Plan, Interventional Clinical Performance Studies, Essential Requirements, Risk Management, UDI and Classification Rules)
- Notifying Bodies (PIP action plan from 2013 – Supervision of Notifying Bodies & Competent Authorities) See link of current NANDO database
12:30–1:00 Registration and networking
1:00–1:15 Opening Remarks
1:15–2:15 Design of Clinical Plans for Global Registrations
2:15–2:30 Networking break
2:30–3:30 Establishing IVDR Compliance within your QMS
3:30–4:30 Panel discussion on clinical research and quality systems
4:30–5:30 Cocktail reception
Meet our Speakers:
Jon E. Marion
Global Operations Manager – IVD
Jon has been in the industry for 18 years with 13 years focused on the IVD industry. Jon spent 4 years with Nanosphere executing clinical studies resulting in the 510k and de novo Clearance and CE Mark approval of highly multiplexed assays for the detection of blood stream infections, enteric pathogens, respiratory pathogens and single nucleotide polymorphisms, among others. He has also led projects to achieve clearances and approvals globally for medical devices, biologicals and pharmaceuticals in the blood banking and cellular therapies industry while with Fresenius Kabi. Jon gained a depth of knowledge in the IVD industry supporting Roche Molecular Diagnostics platforms and assays in roles including training, technical support consultant and complaint handling. Early in Jon’s career, he was a bench scientist in both research and clinical laboratories, rounding his continuum of knowledge from product develop to end-user application.
Jon joined NAMSA in 2018; excited to partner with clients to bring new IVD products to market. Jon has an BS in Biochemistry from The University of Iowa and a MBA from Indiana Wesleyan University. He is a member of Association of Clinical Research Professionals and is a Certified Clinical Research Associate. He also is a member of professional groups related to the IVD and clinical research areas.
Peter C. Ackerman
Principle Medical Research Manager, Quality Systems – IVD
Peter has been in the industry for 25+ years with 15 years focused on IVD and companion diagnostics. While working with Invitrogen and Life Technologies (now ThermoFisher Scientific), Peter helped develop the organization’s Quality Management System for IVDs and Medical Instrumentation, specifically Design Controls, R&D Software Development/Release, QA Release, Systems Validation, Risk Management and Supplier Quality, attaining alignment to US and OUS regulatory agencies. With ThermoFisher Scientific (TFS), he supported the organization as the interim site quality leader, Sr. Director RAQA and CAPA lead, aligning IVD technologies to regulatory requirements, consensus standards and industry best-practices attaining Notifying Body, US and OUS regulatory compliance.
Peter has consulted to Fortune 500 Life Science companies [i.e, JnJ (DepuySynthes, Ethicon & Cordis) Roche Diagnostics, Abbott], midsized organizations (FisherPaykel, Talecris Biotherapeutics, eTherapeutics, 5D information Systems, Amgen) and with multiple emerging technology companies associated with university incubator/Bio start-ups and pre-IPO organizations—developing both their quality systems and regulatory pathways. Currently, Peter holds a BSc in Quality Engineering and Management, and is advancing his MS in RAQA with Temple University. Peter’s current certifications include ASQs Biomedical Auditor (CBA) and Quality Manager/Organizational Excellence (CMQ/OE), Harvard University –Cybersecurity, and is actively pursuing certifications in Machine learning at UC San Diego. Peter is a current member of ACM, ASQ, IEEE, ISACA, Juran Institute, PMI and RAPS.