FDA Pre-Submissions: The Most Valuable Tool in Your US Regulatory Toolbox

12.0
RAC Credits
In-PersonIn-Person EuropeEurope
Tuesday, 21 February 2023 (9:00 AM) - Wednesday, 22 February 2023 (5:00 PM) Central European Time (CET)
Hochstr. 3
München, Germany, 81669

Compiling regulatory dossiers for device registrations is time-consuming and expensive. With the constant changes in the regulatory landscape, it is good to know the expectations and receive FDA feedback for clinical evidence prior to conducting verification, validation, and clinical studies. The U.S. Food and Drug Administration (FDA) offers several mechanisms through which a manufacturer can directly request feedback from the FDA regarding proposed study designs and strategies for medical devices as part of their pre-submission program.

This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.


Learning Objectives

The workshop will provide participants with:

  • Identify the pre-submission options offered by the FDA for obtainingdirect feedback on proposed devices and recognize when the different types of pre-submissions can be used
  • Construct meaningful questions to obtain the necessary feedback to move forward with the next steps in the regulatory pathway
  • Describe the content necessary to complete the different types of pre-submissions
  • Appy learning to example devices and scenarios

Case studies will include both medical and IVD device examples.


REGISTRATION FEES & DEADLINES

Present until January 21, 2023 Early Bird € 975 Member | € 1,155 Nonmember
January 22 – through February 21 2023: Regular € 1,155 Member | € 1,350 Nonmember

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In compliance with regulations, a 19% VAT tax will be charged to all attendees, regardless of your country of origin.

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AGENDA

Day 1 – 21 February 2023

 

9:00 (CEST)

Introduction to FDA’s Q-submission program – What is a Q-submission? What types of Q-submissions are available?

10:30

Break

11:00

Q-submission process – How do I work with FDA to submit, correspond, and close out my Q-submission?

12:30

Lunch

13:30

How to effectively use Q-submissions in your regulatory strategy and tips for successful Q-submissions

15:00

Break

15:30

Case study exercise – Determine regulatory strategy and appropriate Q-submission for example cases

17:00

Close for the Day

 

Day 2 – 22 February 2023

 

9:00 (CEST)

Contents of Q-submissions

10:30

Break

11:00

Submitting Q-submissions electronically (FDA eCopy and eSTAR programs)

12:30

Lunch

13:30

Case study exercise – Determine appropriate Q-submission content and questions for FDA for example cases

15:00

Break

15:30

Case study exercise (continued) and panel Q&A

17:00

Close for the Day

 


Speakers:

Christie Hughes

Christie Hughes, MPH, MSL(ASCP)
Principal Consultant, Qserve Group

Christie Hughes, MPH, MLS(ASCP) is a Principal Consultant and IVD Expert with Qserve Group who has over 25 years of experience in the in vitro diagnostic medical device (IVD) industry. With a degree in medical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges. Christie’s expertise includes regulatory strategy, regulatory submissions, design controls, risk management, QMS implementation, and conducting audits with a focus on compliance with regulations covering the United States (FDA) and Europe (EU IVDR). Her most recent work involves assisting clients with transitioning their technical documentation for legacy IVD devices and assessing their QMS for compliance with EU IVDR requirements.

Lorry Weaver, MLS(ASCP), CLS
Principal Consultant, Qserve Group

Lorry thrives on providing strategic perspectives from a manufacturer’s point of view, having served on Executive Leadership teams at previous companies. Areas of expertise include; global regulatory strategy, regulatory planning, product development life-cycle regulatory applications, and team management.

Her background includes novel and traditional medical devices, as well as in vitro diagnostics across a wide product portfolio. She specializes in global regulatory strategy and planning, design control process and implementation consultation, US FDA submissions (pre-submissions, IDE, 510(k), PMA) and CE-Mark Technical File analyses for EU market access.

Lorry has been in the medical industry for over 30 years, working in large multi-national corporations, mid-sized companies, and clinical laboratories. Primary product areas include: cardiovascular devices and implants, renal devices, ultrasound, and in vitro diagnostics. Lorry's knowledge spans an international level, having had global responsibilities in the US, Europe, and Japan. She earned her BS in Microbiology with a minor in Chemistry from Northern Arizona University, and an MBA at California State University-Sacramento. Additionally, she is a licensed Medical Laboratory Scientist and Clinical Laboratory Scientist with ASCP, NCA, and State of California.

Natalie Batty, MPH
Consultant, Qserve Group

Natalie joined Qserve early 2022 as a consultant and is based in Germany. She has over 6 years of regulatory and clinical affairs experience working with in vitro diagnostics. She has completed multiple FDA submissions (de novos, 510ks, and Emergency Use Authorizations) and has prepared IVD documentation for Canadian and European regulatory agencies.

Natalie started her career in Research and Development working with PCR-based in vitro diagnostic devices for infectious disease testing. She transitioned into the regulatory affairs realm, eventually serving as a regulatory affairs manager for a medical device manufacturing company. In this role, she was responsible for the preparation and management of US regulatory submissions, labeling, and post market surveillance and vigilance. She has extensive experience with quality management systems, risk management, and has completed lead auditor training for ISO 13485. Natalie also has experience with IVD clinical evaluations. She is well-versed in ICH-GCP (Good Clinical Practice) and IVD clinical trial set-up and monitoring activities. Natalie has a strong technical scientific back-ground with a Bachelor’s degree in biology and chemistry, and a Master’s degree in Public Health from the Westminster College in Salt Lake City, Utah.

Location

Holiday Inn Munich – City Centre

Hochstrasse 3
81669 München
Germany

Reservations:

A limited number of rooms is available at the rate of €139.00 + tax.

BOOK ONLINE or call: +49 89 48030

Holiday Inn Munich

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