Baltimore

Baltimore Area Chapter

Wednesday, October 26, 2016

4:45 pm Meet and Greet

5:00 - 6:00 pm Presentation

Location:      Becton Dickinson
               7 Loveton Circle, Sparks, MD 21152

* Note: you will need to stop at security desk and show I.D. upon entering the building.

Room: Maryland Conference Room, 7 Loveton Circle

Please RSVP to: swehage@gmail.com

Presenter:    Edward Fuchs, PA-C, MBA,
                      Associate Director, Drug Development Unit


Presentation:
The Hexamethonium Study and the Death of a Healthy Volunteer: What did We Learn, and how did it Change Us?

 

Learning Objectives:

By the end of the lecture, the attendee will be able to understand:

 

  • The events of the Hexamethonium study and the findings of the investigating committees
  • The impact of this event on research review and research volunteer studies
  • Recent FDA guidance on IND exemptions and how it would have applied to the Hexamethonium study

 

Credits Available: 1 CE credit for SOCRA members

 

Parking:

Please park in garage at 7 Loveton Circle (there is no parking charge)


Directions
:

From the North (I83):

            Take Belfast Road exit, turn left onto Belfast Road and then right onto York Road. At the top of the hill, turn right onto Loveton Circle and then left into the driveway for 7 Loveton Circle. Follow the driveway to the parking garage.

From the South (I83):

            Take the Schwann Road exit and follow Schwann road to York Road. Turn left onto York Road. At the top of the hill, turn left onto the second Loveton Circle entrance. Make an immediate left into the driveway for 7 Loveton Circle and follow to the parking garage.

 

__________________________________________________________________________

SOCRA Baltimore Area Chapter

Wednesday, November 2, 2016

4:45 pm Meet and Greet

5:00 - 6:00 pm Presentation

Location:      Becton Dickinson

                        7 Loveton Circle, Sparks, MD 21152

* Note: you will need to stop at security desk and show I.D. upon entering the building.

 

Room: Maryland Conference Room, 7 Loveton Circle

 

 

Please RSVP to: swehage@gmail.com

 

Presenter:    Jon M. Hirshon, M.D., MPH, Ph.D., Senior Vice Chair, University of Maryland IRB, Professor of Emergency Medicine and Epidemiology

Presentation: Consent or Not to Consent - That is the Question: Ethical Issues in Human Participant Research

 

Learning Objectives:

By the end of the lecture, the attendee will be able to understand:

 

  • Brief historical perspective on research ethics, with a focus on consent
  • US Federal Regulations, with a focus on exception from informed consent (EFIC) research
  • Compare and contrast exceptions from informed consent (EFIC) research with waiver of consent research
  • U of M, Baltimore's Human Research Protection Page

 

Credits Available: 1 CE credit for SoCRA members

 

Parking:

Please park in garage at 7 Loveton Circle (there is no parking charge)

Directions:

From the North (I83):

            Take Belfast Road exit, turn left onto Belfast Road and then right onto York Road. At the top of the hill, turn right onto Loveton Circle and then left into the driveway for 7 Loveton Circle. Follow the driveway to the parking garage.

From the South (I83):

            Take the Schwann Road exit and follow Schwann road to York Road. Turn left onto York Road. At the top of the hill, turn left onto the second Loveton Circle entrance. Make an immediate left into the driveway for 7 Loveton Circle and follow to the parking garage.