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NCRAF Pharm/Bio & Device Workshops
Virtual Event - Webinar Only
Durham, NC 27701
USA
Tuesday, June 09, 2026, 6:00 PM - 8:00 PM EDT
Category: RAC Workshop
The workshops will have live sessions every Tuesday evening, 6 -8 pm US Eastern time; starting June 9, 2026 and running weekly through October 6, 2026; see the confirmation email for all session dates and topics.
ALL sessions will be REMOTE; held via Zoom.
The Zoom meeting info can be found in the confirmation email.
2026 Workshops Agenda (May 1, 2026)
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Lecture topic
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Section
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Lecture
date
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Speaker
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Introduction
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Both
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June 9
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Maria Oyaski
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Regulatory Authority Meetings
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Both
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June 16
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Kevin Barber
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Preclinical Development and GLPs
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Both
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June 23
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Brenda Faiola
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Clinical Protocols and Clinical Development Plans
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Both
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June 30
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Matthew Barnes
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Good Clinical Practices
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Both
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July 7
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David Jensen
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Biologics: Part 1 - the basics
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Pharma/ Biologics
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July 14
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Maria Oyaski
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Device Classification and Regulatory Controls
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Devices
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July 14
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Pending Speaker Confirmation
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CMC (drugs & Biologics)
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Pharma/ Biologics
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July 21
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Olu Aloba
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Medical Device Design Process (Design Controls)
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Devices
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July 21
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Pending Speaker Confirmation
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INDs, IMPDs, CTAs, & CTXs
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Pharma/ Biologics
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July 28
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Kathleen Candando
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IDEs, etc (ex-US device clinical trial submissions)
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Devices
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July 28
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Pending Speaker Confirmation
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Combination Products
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Both
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August 4
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Shilpa Gampa
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Pharmacovigilance
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Both
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August 11
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Pending Speaker Confirmation
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Biologics: Part 2 – Biosimilars, Vaccines, Advanced Therapy Medicinal Products
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Pharma/ Biologics
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August 18
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Maria Oyaski
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Post-Market Activities (e.g. label changes, post-market commitments, maintain/update files)
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Devices
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August 18
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Pending Speaker Confirmation
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NDAs/BLAs, MAAs, JNDAs, NDSs
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Pharma/ Biologics
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August 25
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Sheila Plant
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510(k)s, PMAs, Canada, EU (CE mark, etc), Int.
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Devices
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August 25
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Pending Speaker Confirmation
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Pediatric, Orphan Product and Expanded Access Development for Rare Diseases
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Pharma/ Biologics
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September 1
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Erin O’Reilly
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Special Programs (HDEs, Special Access, etc)
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Devices
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September 1
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Pending Speaker Confirmation
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Pharmaceuticals, Generics, and OTC Drugs
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Pharma/ Biologics
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September 8
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Catherine Maher
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In Vitro Diagnostics, “LDTs”/CLIA, Companion Diagnostics
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Devices
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September 8
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Stefan Burde (EU)
David Jensen (US)
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No Presentation – RAPS Convergence in Charlotte, NC
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September 15
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N/A
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Prescription Product Labeling
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Both
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September 22
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Kamana Singh
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Compliance, Regulatory Inspections, and Enforcement
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Both
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September 29
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Drew Barlow
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Post Marketing
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Both
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October 6
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Patricia Termini
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Contact: [email protected]
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