Regulatory Open Forum

Hi RegEx members,

I hope you have had some time to check out the recently released Regulatory Focus Article Series: The Strategic Role of the Regulatory Professional. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, April 8^th, from 1:30-2:30 PM EST here on RegEx. Two regulatory experts, Amaris Ajamil and Adriana Becker, will be available to discuss the articles and answer your questions in real time.

About the experts:

Amaris Ajamil, PhD, RAC is the senior quality assurance and regulatory affairs engineer at Simbex, a medical device and consumer health product development company. Her quality assurance and regulatory affairs team provides compliance and quality product development oversight including regulatory strategy, usability, risk analysis, verification and validation activities, auditing and continuous process improvements. Ajamil is a strong believer in user-centric design for delivering safe and effective therapies. She holds a doctorate in biomedical engineering from the University of Miami.

Adriana Becker is a senior consultant at Qserve Group with more than a decade's worth of medical devices/biotech industry experience. As part of the regulatory affairs group, Becker's domain of expertise is primarily in EU medical device regulation, currently focused on compliance to the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) for medical devices marketed in the European Union. Becker holds a regulatory science MSc from the University of Southern California.  

If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me an email at regex@raps.org.

Looking forward to hearing your thoughts and reading your questions!

Best Wishes,

Emily

Hi RegEx members,

I hope you have had some time to check out the recently released Regulatory Focus Article Series: The Strategic Role of the Regulatory Professional. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, April 8^th, from 1:30-2:30 PM EST here on RegEx. Two regulatory experts, Amaris Ajamil and Adriana Becker, will be available to discuss the articles and answer your questions in real time.

About the experts:

Amaris Ajamil, PhD, RAC is the senior quality assurance and regulatory affairs engineer at Simbex, a medical device and consumer health product development company. Her quality assurance and regulatory affairs team provides compliance and quality product development oversight including regulatory strategy, usability, risk analysis, verification and validation activities, auditing and continuous process improvements. Ajamil is a strong believer in user-centric design for delivering safe and effective therapies. She holds a doctorate in biomedical engineering from the University of Miami.

Adriana Becker is a senior consultant at Qserve Group with more than a decade's worth of medical devices/biotech industry experience. As part of the regulatory affairs group, Becker's domain of expertise is primarily in EU medical device regulation, currently focused on compliance to the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) for medical devices marketed in the European Union. Becker holds a regulatory science MSc from the University of Southern California.  

If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me an email at regex@raps.org.

Looking forward to hearing your thoughts and reading your questions!

Best Wishes,

Emily

Hi RegEx members,

I hope you have had some time to check out the recently released Regulatory Focus Article Series: The Strategic Role of the Regulatory Professional. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, April 8^th, from 1:30-2:30 PM EST here on RegEx. Two regulatory experts, Amaris Ajamil and Adriana Becker, will be available to discuss the articles and answer your questions in real time.

About the experts:

Amaris Ajamil, PhD, RAC is the senior quality assurance and regulatory affairs engineer at Simbex, a medical device and consumer health product development company. Her quality assurance and regulatory affairs team provides compliance and quality product development oversight including regulatory strategy, usability, risk analysis, verification and validation activities, auditing and continuous process improvements. Ajamil is a strong believer in user-centric design for delivering safe and effective therapies. She holds a doctorate in biomedical engineering from the University of Miami.

Adriana Becker is a senior consultant at Qserve Group with more than a decade's worth of medical devices/biotech industry experience. As part of the regulatory affairs group, Becker's domain of expertise is primarily in EU medical device regulation, currently focused on compliance to the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) for medical devices marketed in the European Union. Becker holds a regulatory science MSc from the University of Southern California.  

If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me an email at regex@raps.org.

Looking forward to hearing your thoughts and reading your questions!

Best Wishes,

Emily