RAPS Workshop: To Pre-Sub, or Not to Pre-Sub, That Is the Question

Registration Fees & Deadlines

Learning Objectives

• Understand the purpose and scope of pre-submissions
• Identify appropriate situations for initiating a pre-submission (pre-sub) vs. proceeding directly with submission
• Prepare complete and high-quality pre-submission requests including development of effective questions
• Develop and execute a strategic plan to effectively prepare for a pre-submission meeting
• Understand techniques to engage in productive interactions with FDA during the pre-submission process
• Interpret and integrate FDA feedback into the regulatory strategy and premarket submission

Who Should Attend?

Who is the intended audience?

• Regulatory Affairs Professionals:
• Regulatory Affairs Specialist
• Regulatory Affairs Manager
• Regulatory Affairs Director
• Medical Device Executives needing to understand the strategy behind Pre-Subs
• Clinical Affairs Professionals of all levels

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Agenda

Speakers

Mark DuVal, JD, FRAPS
CEO, DuVal & Associates, P.A.

Mark DuVal, JD, FRAPS, is the CEO of DuVal & Associates, PA, a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training, and interfacing with the FDA in relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.  He works extensively with FDA on 510(k)s, de novos, PMAs and combination products, IDE negotiations, pre-submissions, inspections, warning letters, appeals, etc.

Lisa Pritchard, BSEEE
Vice President of Regulatory, Quality, Clinical and Engineering

Lisa Pritchard, BSEEE, FRAPS, is vice president of regulatory, quality, clinical & engineering at DuVal & Associates, PA, where she focuses on advising clients on regulatory, quality and compliance topics. Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications FDA submissions such as pre-submissions, IDEs, breakthrough device designations, 510(k)s, De Novos, PMAs, emergency use authorizations, and advisory panel meeting preparation; European design dossiers, technical files, and clinical evaluation plans and reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry. She currently serves as chair of the RAPS Twin Cites Chapter.

Kathy Herzog, BSME
Sr. Regulatory, Quality, and Compliance Associate, DuVal & Associates, PA

Kathy Herzog, BSME, is senior director, regulatory, quality, and compliance at DuVal & Associates, PA. She has worked in the medical device industry for over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and class III products in the orthopedic, neuromodulation, urological, and wound dressing therapeutic areas. She is experienced with US marketing submissions (pre-submissions, IDEs, 510(k)s, De Novos, breakthrough device designation requests, emergency yse authorizations, HUDs/HDES, PMAs and PMA supplements). She also assists clients with quality system, SOP, and labeling development.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions