Regulatory Considerations DMEG

Regulatory Considerations Expert Group

The Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. These include, where to find regulations and being aware of any new ones. Which parts are relevant to data management and what they mean. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

The Regulatory Considerations group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite members to our team. We look forward to hearing from you.

If you have any interest in joining this group, please click here.

Regulatory Considerations Expert Group outputs

ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
Date: June 8, 2021
Click to access output

Data Integrity in Global Clinical Trials
Date: May 27, 2021
Click to access output

FDA 21 CFR Part 11 Subpart B Electronic Records Requirements & Annex 11 Computerised Systems – Suggested Implementation
Date: May 13, 2021
Click to access output

Regulatory Considerations Expert Group members

Silvia Perez Torres (Chair)
Associate Director, Clinical Quality Compliance
AstraZeneca

Although I started my career in the pre-clinical environment, once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working the majority of my career in Data Management, first in a small CRO company and later in the pharma industry.

For almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Aside from the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.

The last two years I have completely changed my role and moved to the Quality area, where I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I am giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management and providing support on audit and inspections, as well as preparing teams to be inspection ready at all times.

Raven Brothers
Associate Director of Clinical Data Abstraction
Natera

Raven Brothers is an expertly skilled clinical research professional with extensive clinical data management and abstraction experience, including managing clinical data collection and developing secondary use real-world deidentified datasets. She is an organized, strategic thinking, seasoned leader capable of managing small and large teams while solving complex problems to achieve business goals. She has a firm grasp of clinical trial operations, GCP, GCDM, DMBOK, DAMABOK, and CFR Title 21 Parts 11, 50, 56, 312, and 812.

Raven grew up in Washington, DC, and graduated from one of the city’s major public high schools. She furthered her education by obtaining a bachelor’s degree in Biology from Elizabeth City State University (2008) and a graduate degree in Clinical Research from The George Washington University (2017). During Raven’s undergraduate studies, she obtained certification as a nursing assistant and during her CNA studies she volunteered at a nursing home. Raven has led an influential career performing clinical data management, including directing peak-performing teams to create and process high-quality clinical unstructured and structured data sets and ensuring staff appropriately apply HIPAA and organizational-wide data handling and de-identification procedures to ensure patient health information protection and privacy.

Raven started her career in less than two weeks upon graduating from her undergrad studies. She joined Westat in 2008 and worked there for close to four years before advancing her career by joining Harris Corporation as a Clinical Data Manager 1 supporting the department of defense’s Vision Center of Excellence Defense and Veterans Eye Injury and Vision Registry (DVEIVR) program. In 2017 Raven left Harris Corporation as a Clinical Staff Supervisor to lead the American Society of Clinical Oncology’s (ASCO) CancerLinQ (CLQ) clinical data management operations. Raven quickly advanced to Project Manager in 2017 and then Associate Director of Commercial Operations in 2019, overseeing all of CLQ’ commercial data activity, including quality assurance and control procedures and the creation of small to large real-world de-identified research datasets for pharma and academic institutions. Additionally, Raven managed all CLQ curation activity performed externally by Tempus and Concert.AI. In October of 2020, Raven joined Natera as Associate Director of Clinical Data Abstraction, where she is overseeing all data abstraction and management activity for the Oncology business unit.

Raven is a member of six professional organizations, ACDM, ACRP, DAMA, PMI, SCDM, and SOCRA, and holds three professional certifications, ACRP-CP, CCRP, and PMP. She is also currently a member of the ACDM Regulatory Expert Working Group.

Throughout the past ten years, Raven has participated in various non-profit organizations and initiatives and enjoys volunteering to support veterans, the elderly, and the homeless. Raven enjoys spending time with her family and fishing. Raven holds herself to high professional ethical standards and approaches each task with three principles she created to define her brand- “I will remain teachable, I will always be approachable and available, and finally, my success is measured by the success of my team and staff.”

Alex Franklin
Project DM Director – Immuno-Oncology
GSK

I have over 20 years experience within the field of Clinical Data Management leading global studies from Phase I and through to Phase IV, within both a CRO and Pharmaceutical environment.

Over the last 10 years I have predominantly been the Data Management lead Oncology and Gene Therapy trials coordinating the end-to-end data management activities for an asset from commit to development through to submission. Most recently I have also been supporting the roll out of new data management tools and processes as well as supporting a number of different initiatives looking at standardisation and process improvements within the group.

As we are moving into a new era of data management; AI, wearables, Decentralised Clinical Trials e.t.c., I am keen to support and help develop our awareness of the changing landscape and the regulatory considerations this will bring.

Julianne Hull
CEO
WenStar Enterprises

With 30 years’ experience Julianne has held global leadership roles in Vendor Management/Outsourcing, Clinical Data Management and Clinical Operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow and Biogen). She is an accomplished global manager and motivator of staff. Julianne received a DIA award for service to the pharmaceutical industry. Julianne is also an honorary life member of the ACDM.

Currently CEO of WenStar Enterprises a company formed in 2011 to provide training and consultancy to the pharmaceutical industry. WenStar Enterprises won a Southern Enterprise Award for Patient Safety earned for training during the COVID-19 epidemic.

Yiannis Karageorgos
Manager of External Data Integration and Data Provisioning
Bristol-Myers Squibb

Ioannis (Yiannis) Karageorgos (Manager of External Data Integration and Data Provisioning at Bristol-Myers Squibb in Belgium) has been involved in clinical research data management for over two decades, at BMS for over 14 years and prior to that at PPD Inc. His expertise includes statistical programming, data management and quality risk management- – working primarily in HIV and Immunoscience/Immuno-Oncology. Yiannis has supported standardization towards interoperability between electronic health records and clinical research through projects including the 2008 EuroREC Clinical Research Functional Profiles, the 2009 ANSI/HL7 clinical research profile, the ISO Technical Committee 215/Joint Initiative Council and the eClinical Forum EHRCR.

He has served as a steering committee member for the eSource Readiness Assessment Projects, the TransCelerate Risk-based Monitoring (RBM) team, the International Network of Clinical Data Management Associations, the French Data Management association and the SCDM Europe, Middle East, and Africa (EMEA) Steering Committee.

He has co-authored the Good Clinical Data Management Practices (GCDMP) Measuring Data Quality and Integrating Data Quality chapters, and several EHR, DM and RBM articles, position & white papers. He has provided comments and presented industry positions to the authorities, on numerous national and international GxP regulations, agency reflection papers and guidance documents over the years.

Mr. Karageorgos holds a Bachelor of Science in Business Administration from the Athens Economic University.

Bertrand Le Bourgeois
President PharMarketing
PharMarketing

Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major software solution providers for Clinical Research and Data Management, and as CIO for a key manufacturer.
Now Bertrand runs PharMarketing, a business development and marketing consultancy, dedicated at helping companies develop in the pharmaceutical sector in EMEA. He is speaking regularly at industry conferences in Europe and in the US, and is President of the French Association of Medical Professionals for Healthcare Products (AMMIS). He sits at the Board of Directors of Data Management Biomedical and is vice-chair of Association for Clinical Data Management.

Karine Renault
Senior Quality Consultant
PharMarketing

I have been in the pharmaceutical industry for over 22 years.

After few years with a CRO company for delivering trainings to Healthcare professionals moving forward to digital environment, I joined lately a US CRO where I spent most of my time (16+ years) as a Technical Quality Engineer for Computerized System Validation and I had opportunity to make many other activities around as well.

Currently working with PharMarketing as Senior Quality Consultant for delivering Data Privacy/GDPR, Computerised System Validation, inspection readiness and other quality compliance services.

I became a member of the ACDM Regulatory Considerations DMEG a few months ago for sharing skills and experience in some specific regulation and related to ER/ES (Electronic Records/Electronic Signatures).

	Silvia Perez Torres (Chair) Associate Director, Clinical Quality Compliance AstraZeneca Click to view biography Although I started my career in the pre-clinical environment, once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working the majority of my career in Data Management, first in a small CRO company and later in the pharma industry. For almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Aside from the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes. The last two years I have completely changed my role and moved to the Quality area, where I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I am giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management and providing support on audit and inspections, as well as preparing teams to be inspection ready at all times.
	Raven Brothers Associate Director of Clinical Data Abstraction Natera Click to view biography Raven Brothers is an expertly skilled clinical research professional with extensive clinical data management and abstraction experience, including managing clinical data collection and developing secondary use real-world deidentified datasets. She is an organized, strategic thinking, seasoned leader capable of managing small and large teams while solving complex problems to achieve business goals. She has a firm grasp of clinical trial operations, GCP, GCDM, DMBOK, DAMABOK, and CFR Title 21 Parts 11, 50, 56, 312, and 812. Raven grew up in Washington, DC, and graduated from one of the city’s major public high schools. She furthered her education by obtaining a bachelor’s degree in Biology from Elizabeth City State University (2008) and a graduate degree in Clinical Research from The George Washington University (2017). During Raven’s undergraduate studies, she obtained certification as a nursing assistant and during her CNA studies she volunteered at a nursing home. Raven has led an influential career performing clinical data management, including directing peak-performing teams to create and process high-quality clinical unstructured and structured data sets and ensuring staff appropriately apply HIPAA and organizational-wide data handling and de-identification procedures to ensure patient health information protection and privacy. Raven started her career in less than two weeks upon graduating from her undergrad studies. She joined Westat in 2008 and worked there for close to four years before advancing her career by joining Harris Corporation as a Clinical Data Manager 1 supporting the department of defense’s Vision Center of Excellence Defense and Veterans Eye Injury and Vision Registry (DVEIVR) program. In 2017 Raven left Harris Corporation as a Clinical Staff Supervisor to lead the American Society of Clinical Oncology’s (ASCO) CancerLinQ (CLQ) clinical data management operations. Raven quickly advanced to Project Manager in 2017 and then Associate Director of Commercial Operations in 2019, overseeing all of CLQ’ commercial data activity, including quality assurance and control procedures and the creation of small to large real-world de-identified research datasets for pharma and academic institutions. Additionally, Raven managed all CLQ curation activity performed externally by Tempus and Concert.AI. In October of 2020, Raven joined Natera as Associate Director of Clinical Data Abstraction, where she is overseeing all data abstraction and management activity for the Oncology business unit. Raven is a member of six professional organizations, ACDM, ACRP, DAMA, PMI, SCDM, and SOCRA, and holds three professional certifications, ACRP-CP, CCRP, and PMP. She is also currently a member of the ACDM Regulatory Expert Working Group. Throughout the past ten years, Raven has participated in various non-profit organizations and initiatives and enjoys volunteering to support veterans, the elderly, and the homeless. Raven enjoys spending time with her family and fishing. Raven holds herself to high professional ethical standards and approaches each task with three principles she created to define her brand- “I will remain teachable, I will always be approachable and available, and finally, my success is measured by the success of my team and staff.”
	Alex Franklin Project DM Director – Immuno-Oncology GSK Click to view biography I have over 20 years experience within the field of Clinical Data Management leading global studies from Phase I and through to Phase IV, within both a CRO and Pharmaceutical environment. Over the last 10 years I have predominantly been the Data Management lead Oncology and Gene Therapy trials coordinating the end-to-end data management activities for an asset from commit to development through to submission. Most recently I have also been supporting the roll out of new data management tools and processes as well as supporting a number of different initiatives looking at standardisation and process improvements within the group. As we are moving into a new era of data management; AI, wearables, Decentralised Clinical Trials e.t.c., I am keen to support and help develop our awareness of the changing landscape and the regulatory considerations this will bring.
	Julianne Hull CEO WenStar Enterprises Click to view biography With 30 years’ experience Julianne has held global leadership roles in Vendor Management/Outsourcing, Clinical Data Management and Clinical Operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow and Biogen). She is an accomplished global manager and motivator of staff. Julianne received a DIA award for service to the pharmaceutical industry. Julianne is also an honorary life member of the ACDM. Currently CEO of WenStar Enterprises a company formed in 2011 to provide training and consultancy to the pharmaceutical industry. WenStar Enterprises won a Southern Enterprise Award for Patient Safety earned for training during the COVID-19 epidemic.
	Yiannis Karageorgos Manager of External Data Integration and Data Provisioning Bristol-Myers Squibb Click to view biography Ioannis (Yiannis) Karageorgos (Manager of External Data Integration and Data Provisioning at Bristol-Myers Squibb in Belgium) has been involved in clinical research data management for over two decades, at BMS for over 14 years and prior to that at PPD Inc. His expertise includes statistical programming, data management and quality risk management- – working primarily in HIV and Immunoscience/Immuno-Oncology. Yiannis has supported standardization towards interoperability between electronic health records and clinical research through projects including the 2008 EuroREC Clinical Research Functional Profiles, the 2009 ANSI/HL7 clinical research profile, the ISO Technical Committee 215/Joint Initiative Council and the eClinical Forum EHRCR. He has served as a steering committee member for the eSource Readiness Assessment Projects, the TransCelerate Risk-based Monitoring (RBM) team, the International Network of Clinical Data Management Associations, the French Data Management association and the SCDM Europe, Middle East, and Africa (EMEA) Steering Committee. He has co-authored the Good Clinical Data Management Practices (GCDMP) Measuring Data Quality and Integrating Data Quality chapters, and several EHR, DM and RBM articles, position & white papers. He has provided comments and presented industry positions to the authorities, on numerous national and international GxP regulations, agency reflection papers and guidance documents over the years. Mr. Karageorgos holds a Bachelor of Science in Business Administration from the Athens Economic University.
	Bertrand Le Bourgeois President PharMarketing PharMarketing Click to view biography Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major software solution providers for Clinical Research and Data Management, and as CIO for a key manufacturer. Now Bertrand runs PharMarketing, a business development and marketing consultancy, dedicated at helping companies develop in the pharmaceutical sector in EMEA. He is speaking regularly at industry conferences in Europe and in the US, and is President of the French Association of Medical Professionals for Healthcare Products (AMMIS). He sits at the Board of Directors of Data Management Biomedical and is vice-chair of Association for Clinical Data Management.
	Karine Renault Senior Quality Consultant PharMarketing Click to view biography I have been in the pharmaceutical industry for over 22 years. After few years with a CRO company for delivering trainings to Healthcare professionals moving forward to digital environment, I joined lately a US CRO where I spent most of my time (16+ years) as a Technical Quality Engineer for Computerized System Validation and I had opportunity to make many other activities around as well. Currently working with PharMarketing as Senior Quality Consultant for delivering Data Privacy/GDPR, Computerised System Validation, inspection readiness and other quality compliance services. I became a member of the ACDM Regulatory Considerations DMEG a few months ago for sharing skills and experience in some specific regulation and related to ER/ES (Electronic Records/Electronic Signatures).