9th Annual Fall Symposium
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Speakers:
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Juddson Rupp, Patient Advocacy Manager
Milestone Pharmaceuticals
Brian R. Wamhoff, Ph.D., Vice President Research & Development
HemoShear, LLC (Charlottesville)
Jaclyn Lautz PhD, Vice President of Research & Development
ivWatch (Williamsburg)
Jeff Pompeo President and CEO
Caretaker Medical Corp (Charlottesville)
Joann Peters, MHA
Vice President, Clinical Operations
Geneos Therapeutics, Inc. (Charlottesville)
Food and Drug Administration (FDA)
Daniel Walter
Assistant Director, Obesity and Hepatobiliary Devices Team
Office of Product Evaluation and Quality
Center for Devices and Radiological Health (CDRH), FDA
Anita S. Kablinger MD, CPI, FAAP, FAPA, FACRP
Professor and Program Director Clinical Trials Research
Department of Psychiatry and Behavioral Medicine
Carilion Clinic-Virginia Tech Carilion School of Medicine
Barbara van der Shalie
Clinical Training Manager
Leidos Biomedical Research, Inc.
Raymond Nomizu, JD, Co-founder of Clinical Research IO
Clinical Research IO
Michael Keens, MS
Chief Operating Officer
Firma Clinical Research
Jim Wise, MS
Executive Director, Project Delivery
PRA Health Sciences
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Program Agenda:
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08:00 – 08:15 AM
Opening Remarks & Business Meeting
Barry Herndon
ACRP Central Virginia Chapter President
Senior CRA, ICON Clinical Research
08:15 – 09:15 AM
Presentation Session: Patient Advocacy – A Personal Story
Juddson Rupp, Patient Advocacy Manager
Milestone Pharmaceuticals
09:15 – 10:45 AM
Panel Discussion Session: Local Biotech –
Incorporating patient centricity into clinical development programs
Brian R. Wamhoff, Ph.D., Vice President Research & Development
HemoShear, LLC (Charlottesville)
Jaclyn Lautz PhD, Vice President of Research & Development
ivWatch (Williamsburg)
Jeff Pompeo President and CEO
Caretaker Medical Corp (Charlottesville)
Joann Peters, MHA
Vice President, Clinical Operations
Geneos Therapeutics, Inc. (Charlottesville)
10:45 – 11:00 AM Break
11:00 – 12:15 PM
KEYNOTE Presentation Session:
Food and Drug Administration (FDA)
Daniel Walter
Assistant Director, Obesity and Hepatobiliary Devices Team
Office of Product Evaluation and Quality
Center for Devices and Radiological Health (CDRH), FDA
12:15 – 01:15 PM
Lunch Session with Roundtable:
Discussions of Clinical Research Career Paths
Anita S. Kablinger MD, CPI, FAAP, FAPA, FACRP
Professor and Program Director Clinical Trials Research
Department of Psychiatry and Behavioral Medicine
Carilion Clinic-Virginia Tech Carilion School of Medicine
01:15 – 02:30 PM
Presentation Session: Resiliency in the Workplace
Barbara van der Shalie
Clinical Training Manager
Leidos Biomedical Research, Inc.
02:30 – 02:45 PM Break
02:45 – 03:45 PM
Presentation Session: Paperless Clinical Trials
Raymond Nomizu, JD, Co-founder of Clinical Research IO
Clinical Research IO
03:45 – 04:45 PM
Multi-Speaker Presentation Session:
Personalized Medicine in Clinical Trials
Michael Keens, MS
Chief Operating Officer
Firma Clinical Research
Joann Peters, MHA
Vice President, Clinical Operations
Geneos Therapeutics, Inc.
Jim Wise, MS
Executive Director, Project Delivery
PRA Health Sciences
5:00 PM
Final Closing Remarks
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Program Description: A full day event that will allow you the opportunity to earn up to 7.5 educational contact hours and network with other clinical research professionals. Come and be part of the local area biotech discussions, hear about the state of affairs at the FDA, incorporate patient advocacy and patient centricty, learn about new clinical trial trends such as personalized medicine and paperless clinical trials, professional development sessions and more!
Upon completion of this Seminar, attendees should be able to:
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1. Identify innovative patient engagement initiatives in relation to advocacy.
2. Describe how clinical trials and biotech companies are being impacted by patient
advocacy.
3. List performance actions that can facilitate the progression of clinical research career
paths.
4. Examine diverse aspects of resiliency in the workplace including the importance,
components, and development of resilience.
5. Review paperless clinical trial trends and describe recommended compliance
documentation for electronic systems.
6. Define individual medicine terms “Precision” versus “Personalized” and forecast
treatment trends for personalized medicines.
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Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Quality Assurance
- Clinical Research Administrators
Registration and Contact Hour Cost:
Early-Bird Rates: (ends October 2, 2019)
- Chapter Members $100
- ACRP Member Registration Only: $115
- ACRP Member Registration & Contact Hours: $150
- Non Member Registration Only: $135
- Non Member Registration & Contact Hours: $185
Regular Rates (
after October 2, 2019)
- Chapter Members $125
- ACRP Member Registration Only: $140
- ACRP Member Registration & Contact Hours: $175
- Non Member Registration Only: $160
- Non Member Registration & Contact Hours: $210
Contact hours: 7.5 ACRP contact hours are approved for this event
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program.
Log on to the ACRP website “Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Refund Policy: Not applicable
Location and Parking Information:
We are hosting this year's event at the Abbott Auditorium Center within Darden's School of Business on 100 Darden Boulevard, Charlottesville, Virginia.
As you enter the campus, you will arrive on Duffy Boulevard, continue straight ahead toward the building, turn right for the garage to park.
The gate will be open and you will not incur any parking fees.
There will be signs to direct you to the Abbott Center Auditorium.
THANK YOU to our Sponsors!
Level Sponsor Website
Gold Fleet https://www.prestigebrands.com/fleet/
Gold iTHRIV https://portal.ithriv.org/#/home
AND
http://ithriv.org
Gold Carilion Clinic https://www.carilionclinic.org/research#clinical-trials
Silver Focused Ultrasound Foundation www.fusfoundation.org
Bronze BrightSpec http://brightspec.com