Regulatory Open Forum

Hi RegEx members,

 I hope you have had some time to check out the recently released Regulatory Focus Article Series: Global Regulatory Strategies and Best Practices. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 12 June, from 1:30-2:30 PM EDT here on RegEx. Four global regulatory strategy experts, Allison C. Komiyama, Emily Huddle, Kirsten Messmer, and Melissa Walker will be available to discuss the articles and answer your questions in real time.

About the experts:

Allison C. Komiyama, PhD, RAC, is principal consultant at AcKnowledge Regulatory Strategies, LLC. She has 15 years of experience in life sciences with keen interest in developing regulatory strategies for medical device companies, authoring submissions and assisting new technologies in entering the US and global markets.

Emily Huddle is US senior regulatory intelligence manager for Gilead Sciences, Inc. and (outgoing) co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including 10 years in regulatory intelligence.

Kirsten Messmer, PhD, RAC, is a principal regulatory affairs specialist in regulatory intelligence solutions at PPD. She is co-chair of the DIA Regulatory Intelligence Working Group. Messmer received a PhD in neuroscience from the University of Sheffield, UK.

Melissa Walker, MS, RAC, FRAPS, is an inventor and the founder of Graematter, Inc, a regulatory intelligence firm.  Prior to founding the Company, she served in multiple senior executive positions where she was responsible for the regulatory, quality systems, and clinical research functions, including submissions, complaint-handling, regulatory compliance, clinical research, and healthcare compliance.

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: Global Regulatory Strategies and Best Practices. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 12 June, from 1:30-2:30 PM EDT here on RegEx. Four global regulatory strategy experts, Allison C. Komiyama, Emily Huddle, Kirsten Messmer, and Melissa Walker will be available to discuss the articles and answer your questions in real time.

About the experts:

Allison C. Komiyama, PhD, RAC, is principal consultant at AcKnowledge Regulatory Strategies, LLC. She has 15 years of experience in life sciences with keen interest in developing regulatory strategies for medical device companies, authoring submissions and assisting new technologies in entering the US and global markets.

Emily Huddle is US senior regulatory intelligence manager for Gilead Sciences, Inc. and (outgoing) co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including 10 years in regulatory intelligence.

Kirsten Messmer, PhD, RAC, is a principal regulatory affairs specialist in regulatory intelligence solutions at PPD. She is co-chair of the DIA Regulatory Intelligence Working Group. Messmer received a PhD in neuroscience from the University of Sheffield, UK.

Melissa Walker, MS, RAC, FRAPS, is an inventor and the founder of Graematter, Inc, a regulatory intelligence firm.  Prior to founding the Company, she served in multiple senior executive positions where she was responsible for the regulatory, quality systems, and clinical research functions, including submissions, complaint-handling, regulatory compliance, clinical research, and healthcare compliance.

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: Global Regulatory Strategies and Best Practices. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 12 June, from 1:30-2:30 PM EDT here on RegEx. Four global regulatory strategy experts, Allison C. Komiyama, Emily Huddle, Kirsten Messmer, and Melissa Walker will be available to discuss the articles and answer your questions in real time.

About the experts:

Allison C. Komiyama, PhD, RAC, is principal consultant at AcKnowledge Regulatory Strategies, LLC. She has 15 years of experience in life sciences with keen interest in developing regulatory strategies for medical device companies, authoring submissions and assisting new technologies in entering the US and global markets.

Emily Huddle is US senior regulatory intelligence manager for Gilead Sciences, Inc. and (outgoing) co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including 10 years in regulatory intelligence.

Kirsten Messmer, PhD, RAC, is a principal regulatory affairs specialist in regulatory intelligence solutions at PPD. She is co-chair of the DIA Regulatory Intelligence Working Group. Messmer received a PhD in neuroscience from the University of Sheffield, UK.

Melissa Walker, MS, RAC, FRAPS, is an inventor and the founder of Graematter, Inc, a regulatory intelligence firm.  Prior to founding the Company, she served in multiple senior executive positions where she was responsible for the regulatory, quality systems, and clinical research functions, including submissions, complaint-handling, regulatory compliance, clinical research, and healthcare compliance.

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: Global Regulatory Strategies and Best Practices. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 12 June, from 1:30-2:30 PM EDT here on RegEx. Four global regulatory strategy experts, Allison C. Komiyama, Emily Huddle, Kirsten Messmer, and Melissa Walker will be available to discuss the articles and answer your questions in real time.

About the experts:

Allison C. Komiyama, PhD, RAC, is principal consultant at AcKnowledge Regulatory Strategies, LLC. She has 15 years of experience in life sciences with keen interest in developing regulatory strategies for medical device companies, authoring submissions and assisting new technologies in entering the US and global markets.

Emily Huddle is US senior regulatory intelligence manager for Gilead Sciences, Inc. and (outgoing) co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including 10 years in regulatory intelligence.

Kirsten Messmer, PhD, RAC, is a principal regulatory affairs specialist in regulatory intelligence solutions at PPD. She is co-chair of the DIA Regulatory Intelligence Working Group. Messmer received a PhD in neuroscience from the University of Sheffield, UK.

Melissa Walker, MS, RAC, FRAPS, is an inventor and the founder of Graematter, Inc, a regulatory intelligence firm.  Prior to founding the Company, she served in multiple senior executive positions where she was responsible for the regulatory, quality systems, and clinical research functions, including submissions, complaint-handling, regulatory compliance, clinical research, and healthcare compliance.

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