2026 NCRAF Workshops Agenda
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|
Lecture topic |
Section |
Lecture |
Speaker |
|
Introduction |
Both |
June 9 |
Maria Oyaski |
|
Regulatory Authority Meetings |
Both |
June 16 |
Kevin Barber |
|
Preclinical Development and GLPs |
Both |
June 23 |
Brenda Faiola |
|
Clinical Protocols and Clinical Development Plans |
Both |
June 30 |
Matthew Barnes |
|
Good Clinical Practices |
Both |
July 7 |
David Jensen |
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Biologics: Part 1 - the basics |
Pharma/ Biologics |
July 14 |
Maria Oyaski |
|
Device Classification and Regulatory Controls |
Devices |
July 14 |
Pending Speaker Confirmation |
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CMC (drugs & Biologics) |
Pharma/ Biologics |
July 21 |
Olu Aloba |
|
Medical Device Design Process (Design Controls) |
Devices |
July 21 |
Pending Speaker Confirmation |
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INDs, IMPDs, CTAs, & CTXs |
Pharma/ Biologics |
July 28 |
Kathleen Candando |
|
IDEs, etc (ex-US device clinical trial submissions) |
Devices |
July 28 |
Pending Speaker Confirmation |
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Combination Products |
Both |
August 4 |
Shilpa Gampa |
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Pharmacovigilance
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Both |
August 11 |
Pending Speaker Confirmation |
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Biologics: Part 2 – Biosimilars, Vaccines, Advanced Therapy Medicinal Products |
Pharma/ Biologics |
August 18 |
Maria Oyaski |
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Post-Market Activities (e.g. label changes, post-market commitments, maintain/update files) |
Devices |
August 18 |
Pending Speaker Confirmation |
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NDAs/BLAs, MAAs, JNDAs, NDSs |
Pharma/ Biologics |
August 25 |
Sheila Plant |
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510(k)s, PMAs, Canada, EU (CE mark, etc), Int. |
Devices |
August 25 |
Pending Speaker Confirmation |
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Pediatric, Orphan Product and Expanded Access Development for Rare Diseases |
Pharma/ Biologics |
September 1 |
Erin O’Reilly |
|
Special Programs (HDEs, Special Access, etc) |
Devices |
September 1 |
Pending Speaker Confirmation |
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Pharmaceuticals, Generics, and OTC Drugs |
Pharma/ Biologics |
September 8 |
Catherine Maher |
|
In Vitro Diagnostics, “LDTs”/CLIA, Companion Diagnostics |
Devices |
September 8 |
Stefan Burde (EU) David Jensen (US) |
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No Presentation – RAPS Convergence in Charlotte, NC |
|
September 15 |
N/A |
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Prescription Product Labeling |
Both |
September 22 |
Kamana Singh |
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Compliance, Regulatory Inspections, and Enforcement |
Both |
September 29 |
Drew Barlow |
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Post Marketing |
Both |
October 6 |
Patricia Termini |
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