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19 May 2021 | 02:30 PM GMT

Masterclass: The Regulation of DTx in the US

Anchored by:

Jason Brooke
Attorney & Managing Member
BROOKE CONSULTING
Rick Bartels
President/Founder
DTXCC

Participants:

Jason Brooke Attorney & Managing MemberBrooke Consulting
Jason Brooke
Attorney & Managing MemberBrooke Consulting
Rick Bartels President/Founder DTxCC
Rick Bartels
President/Founder DTxCC
Elan Tye Venture Partner (AI, Health, Deep Tech)Stealth
Elan Tye
Venture Partner (AI, Health, Deep Tech)Stealth
Eliza Silvester Senior PrincipalIQVIA
Eliza Silvester
Senior PrincipalIQVIA
Hassan Naqvi Lead Digital Health CommercializationAstraZeneca
Hassan Naqvi
Lead Digital Health CommercializationAstraZeneca
Jessica Shull Director of Digital HealthVicore Pharma
Jessica Shull
Director of Digital HealthVicore Pharma
Jim Howard CEOReadout Health
Jim Howard
CEOReadout Health
Joseph Rubinsztain CEOChronWell
Joseph Rubinsztain
CEOChronWell
Kasparas Aleknavicius Medical AdvisorKilo.Health
Kasparas Aleknavicius
Medical AdvisorKilo.Health
Kristinn Gylfason Head of ComplianceSidekickHealth
Kristinn Gylfason
Head of ComplianceSidekickHealth
Laura Joglekar Senior Director, Material SciencesBristol Myers Squibb
Laura Joglekar
Senior Director, Material SciencesBristol Myers Squibb
Mayely Paola Sánchez Espinosa Senior Digital Data Scientist, R&DAlmirall
Mayely Paola Sánchez Espinosa
Senior Digital Data Scientist, R&DAlmirall
Mayely Paola Sanchez Espinosa Senior Digital Data Scientist, R&DAlmirall
Mayely Paola Sanchez Espinosa
Senior Digital Data Scientist, R&DAlmirall
Natalie Principe Member Board of Directors and Management TeamActual Healthcare Solutions
Natalie Principe
Member Board of Directors and Management TeamActual Healthcare Solutions
Todd Greenwood Sr. Director Evidence Generation and OutcomesZS Associates
Todd Greenwood
Sr. Director Evidence Generation and OutcomesZS Associates
Todd Greenwood Director Evidence GenerationZS Associates
Todd Greenwood
Director Evidence GenerationZS Associates

About this Meeting

Regulation is an absolute essential for  DTx companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your DTx product through regulatory pathways in the US? Join us in this Masterclass led by AmalgamRx to learn more about:
 -The evolution of the US regulatory regimes for SaMD: FDA Pre-Cert program 
 -What should DTx companies go after as a SaMD maker - de novo, breakthrough      device or classic 510k? 
 -FDA Digital Health Center of Excellence (DHCoE): focus and roadmap 
 -Changes expected in the US regulatory regimes for SaMD in the next 2 years