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Global Emergency Use Authorizations (EUAs) & Accelerated Vaccine Development

May 14, 2020 @ 8:00 am - 10:00 am

Educational Opportunity

Global Emergency Use Authorizations (EUAs) & Accelerated Vaccine Development

 

May 14th, 2020

3:00 pm – 5:00 pm

 

2.0 Hours Towards Your RAC Recertification

 We will explore time critical questions on Emergency Use Authorizations (EUA) Medical Device Regulatory Market Access and Accelerated Development of Vaccines, and Therapeutics against the COVID-19 Pandemic. On the Medical Device or Diagnostics side, we will address how EUAs are used to get a medical device approved quickly in response to COVID-19 and how regulators including the FDA, European Commission and TGA are reacting to the global pandemic. On the Therapeutics and Vaccine side, we will address current FDA and EU Regulatory Agency Handling of accelerated development of vaccines and therapeutics.  Examples of current vaccines and treatments in development will be discussed. During the presentation we will discuss the landscape of vaccines and therapeutics for COVID-19, the regulatory framework for initiation of clinical studies and possible timelines for approvals.

 

Location:  Webinar

Program Manager:  Luis Jimenez, Chem E., MBA, VP of Business Development Brandwood CKC

Online Registration:  https://www.eventbrite.com/e/global-emergency-use-authorizations-euas-accelerated-vaccine-development-tickets-103263999402

 

Speakers:  

Arthur Brandwood, PhD, FRAPs,
Director and Principal Consultant, Brandwood CKC

Adam Lambert, PhD,
CMC Consultant/Regulatory Affairs

Cost:

  • OCRA Members: $25
  • Non-Members: $25 (We are waiving the requirement for OCRA membership for this event)
  • Government and Student Members: $10, with student/government ID

 

Presentation Overviews:

Medical Device Regulatory Market Access amidst a Pandemic

During this presentation we will address key regulatory strategies to respond to the impacts of the COVID-19 Pandemic while managing the disrupted supply chains, shortages of medicines, masks, ventilators and test kits. The topics that will be covered include:

  • Emergency Use Applications (EMA), without product registrations
  • Expedited reviews
  • Waivers of change applications

We will also address the risk benefit ratio to address regulator’s expectations to see some sort of evidence of safety and efficacy, though it may be much more flexibly interpreted.

During his presentation Dr. Brandwood will address how to get a medical device or medicine approved quickly in response to COVID-19 and how to regulators including the FDA, European Commission and TGA are reacting to the global pandemic.

Accelerated Development of Vaccines, and Therapeutics against COVID-19

During this presentation we will address current FDA and EU Regulatory Agency Handling of accelerated development of vaccines and therapeutics.  Examples of current vaccines and treatments in development will be discussed. Topics Include:

  • COVID-19 Vaccine Development
  • Development of COVID-19 Therapeutics
  • FDAs Coronavirus Treatment Acceleration Program (CTAP)
  • COVID-19 EMA pandemic Task Force

During his presentation Dr. Lambert will discuss the landscape of vaccines and therapeutics for COVID-19, the regulatory framework for initiation of clinical studies and possible timelines for approvals.

 

Speaker Bios

 

 

Arthur Brandwood, PhD, FRAPs

Director and Principal Consultant

Arthur Brandwood has spent more than 30 years in the medical devices sector working across industry, academia and government. Senior government roles have included Director of Device Registrations and Assessment at TGA and he has also served as Chair of the Regulatory expert panel for industry association AusMedtech. Over the past 20 years Arthur has provided expert consulting services to a global clientele ranging from start-ups to top tier multinationals. With deep expertise in biocompatibility and biomaterials development, Arthur’s published research includes the development of commercialized implant materials. He has served as President of the Australian Society for Biomaterials and Tissue Engineering. He is a Fellow of the Regulatory Affairs Professionals Society (RAPS) and provides advice and guidance to regulatory agencies, particularly in emerging markets, and serves as Advisor to the Asian Harmonization Working Party. He is also visiting Professor at the University of Sydney where he teaches regulatory affairs to biomedical engineers.

 

Adam Lambert, PhD, CMC Consultant/Regulatory Affairs
Dr. Lambert has spent more than 20 years in drug product CMC development of complex pharmaceuticals. Adam has served in leadership positions and provided professional consulting for regulatory CMC strategy with multiple product approvals to his credit.  During his tenure he has developed vaccines, therapeutics, and combination device/drug products. He participated in academic/industry collaborations receiving multiple grant awards supporting the development of novel products. He has served as Adjunct Professor at University of South Florida School of Pharmacy, mentoring PharmD. candidates in industrial pharmaceutical development.   

 

OCRA Registration Instructions

To register for this event go to:  https://www.eventbrite.com/e/global-emergency-use-authorizations-euas-accelerated-vaccine-development-tickets-103263999402

 

Registration deadline is May 13th, 11:59pm

 

OCRA’s non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline

For a refund, please request a refund through Eventbrite by May 13th, 3pm

If you have any questions or require additional information, email OCRA Program Chair (ocraprogramchair@gmail.com).

 

Location: Webinar

Venue

Webinar