University City (PA)
SOCRA University City Chapter
9:00 - 10:00 Lecture
10:00 - 10:30 Q&A
10:30 - 11:00 Networking
FEATURE PRESENTOR: Sylvia L. Johnson, MS - CEO/President of JI-Solutions LLC
This lecture aims to provide an overview of how regulations impact clinical studies. By the end of the lecture, attendees will be able to understand: clinical study oversight, FDA site inspection, role of the FDA/Sponsor/IRB, what drives a successful clinical study and what are the real expectations.
ABOUT THE SPEAKER:
Sylvia L. Johnson is the CEO/President of JI-Solutions LLC a Health IT and Biomedical Consulting Company headquartered in Baltimore Md. She has over 25 years in the Pharmaceutical/Biotechnology industry. She specializes in Cell Biology and Hematology having worked for the NIH/NCI in Transplantation Biology and the FDA/CBER as a Research Scientist, Regulatory Reviewer, Compliance Officer and Lead Inspector. Ms. Johnson managed the inspections program for Vaccines, Therapeutic Products and various Clinical Studies.
Ms. Johnson assisted in the establishment of FDA's Team Biologics which consisted of a Team of Specialized Inspectors and Scientists assigned to inspections that often resulted in compliance or enforcement actions. Before leaving the FDA; Ms. Johnson worked for the FDA Commissioner in the Office of International Affairs. During this assignment Ms. Johnson was selected to represent CBER on the Mutual Recognitions Agreement between the US/EU Member States. Ms. Johnson has enjoyed an illustrious career in the industry holding senior level positions in which she impacted successful organizational changes. Ms. Johnson will be a guest presenter at SOCRA's National Conference in New Orleans 2018.
Ms. Johnson and her team continue to support the Pharma/Biotech industry through difficult compliance needs by offering proven strategic solutions. She is also a Best-Selling Author of the book "Daily Dose of Direction for Women in Business" inspiring other women CEOs to share their journey.
Program is FREE and is open to both SOCRA & Non-SOCRA members. Registration is not required.
SOCRA members may claim up to 1.5 SOCRA CEU for SOCRA recertification. SOCRA members will receive a certificate of attendance.
Contact Kristi Lelionis, MS, CCRP, Chapter Chair at firstname.lastname@example.org
This meeting will be held in the Austrian Auditorium, Clinical Research Building (CRB), the University of Pennsylvania, 415 Curie Boulevard, Philadelphia, PA 19104
CRB is approximately a10 minute walk from the University City station (SEPTA Regional Rail)
SEPTA Regional Rail: The Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains provide direct service to the University City Station. From other Regional Rail lines, transfer free to the Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains at 30th Street or Market East stations. Your train ticket is your transfer.
SEPTA City Trains and Trolleys: The SEPTA Market/Frankford Blue Line (the elevated train/subway) stops at 34th and Market Sts. The CRB is approximately a 15 minute walk from there. All SEPTA Subway/Surface Green Line trolleys except the Number 10 stop at 37th and Spruce streets; it is less than a 10 minute walk to the CRB.
Loop Through University City (LUCY): The LUCY Gold Loop takes passengers from 30th Street Station and 34th and Market Streets to Curie Blvd (in front of the Biomedical Research Building - BRB) and then onto Penn Presbyterian Medical Center (PPMC).The Gold Loop shuttle runs every 10 minutes during peak times (7 a.m. to 9 a.m. and 4 p.m. to 6 p.m.) and every 30 minutes from 9 a.m. to 4 p.m.LUCY is $2.00 for the public and is free with a SEPTA pass or ID from the University of Pennsylvania, University of Pennsylvania Health System, Drexel University, Children's Hospital of Philadelphia and the VA Medical Center.
**Charges apply** and are the responsibility of the attendee. Please note that the available parking garages are several blocks from the Clinical Research Building (CRB).
Public parking is available at the 3600 Civic Center Boulevard, Chestnut 34 and the Penn Museum Garages. View Penn Parking Map
Valet parking is available at the Hospital of the University of Pennsylvania (HUP). Self-parking and valet parking is available at the Perelman Center for Advanced Medicine (PCAM). Parking at both HUP and PCAM are primarily reserved for patients and their families, with limited parking for campus visitors.
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