Activity Type
- Application
Target Audience(s)
- Pharmacist
- Pharmacy Technician
Accreditation(s)
CPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education
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Requirements for CE Credit
Objectives
- Describe the United States drug development process
- Define clinical trial transparency and why we need it
- Discuss the ethical dilemmas arising from disclosing too much, too little, or incomplete data
- Recognize the key events leading to the adoption of disclosure regulations
- Discuss guidelines and regulations governing clinical trial disclosure
- Develop a working knowledge of the types of trials in scope of disclosure to various public registries
- Define the regulatory timelines that must be adhered to when disclosing summaries
- Predict future disclosure trends
- Discuss current compliance standings, and key contributors to lack of compliance with disclosure regulations across the industry
- Develop a working knowledge of the two most widely used public registries (ClinicalTrials.gov and the European Union Clinical Trial Register)
- Search and view study records, and access the resources and guidances available in each registry
- Manage records, user accounts, and workflow in the Protocol Registration and Results System (PRS) and the European Clinical Trials Database (EudraCT).
- Define mandatory field-level data elements, highlight specific field validations, and discuss the differences and similarities between the two registration systems.
- Review source documents used in summarizing data
- Assess criteria used to determine if a study is in scope of federal requirements
- Define the characteristics of the different types of studies that can be registered, as well as initial guidelines that should be followed when summarizing data
- Describe clinical trial protocols
- Glean data from an actual clinical trial protocol and populate an interventional protocol registration within PRS, focusing on mandatory data elements
- Define the key differences between non-interventional registrations and interventional registrations
- Glean data from excerpts from a clinical study report (CSR) and populate an interventional results summary within PRS, focusing on mandatory data elements
- Provide an overview of the international registries mandating protocol registration and results disclosure
Speaker(s)/Author(s)
Joe Archer, B Health Care Administration
Brief Bio : Mr. Joe Archer is the Associate Director, Trial Disclosure Services, and instrumental in the launch and growth of the clinical trial disclosure business at MMS. Mr. Archer has over 25 years of experience in clinical research and is a subject matter expert of processes and systems related to the reporting of clinical trial information to ClinicalTrials.gov, EudraCT, and additional registries globally. Prior to holding this role, Mr. Archer was Senior Manager, Clinical Trial Disclosures at GlaxoSmithKline from 2007 to 2011 where he led the development and oversight of systems, processes, quality controls and compliance of clinical disclosure reporting of the company’s protocol and results summary information. He has also held various positions of increasing responsibility in the Regulatory Quality Control and Strategic Operations divisions of INC Research, Pfizer, and Parke-Davis. Mr. Archer earned a Bachelor of Science degree in Health Care Administration from Eastern Michigan University. |
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Kasim McLain, BS
Brief Bio : Kasim McLain has over 15 years of experience in regulatory affairs, medical writing, and clinical trial disclosures, with 8 of those years spent specifically in disclosures. She has worked for both sponsor companies and CROs, and has successfully trained upward of 20 colleagues to be clinical disclosure leads and summary writers. Additionally, Kasim has experience with developing key disclosures process documents, implementing these processes, and conducting training programs to ensure compliance with these processes. Kasim also has a Regulatory Affairs Certification, demonstrating an overarching understanding of the regulations governing clinical drug development and a nuanced understanding of those governing clinical trial disclosures. Kasim is currently Manager of Disclosure Services at MMS Holdings, Inc. and holds a Bachelor of Science degree from Roanoke College. |
Activity Number
0864-0000-17-087-H04-P
Objectives
- Describe the United States drug development process
- Define clinical trial transparency and why we need it
- Discuss the ethical dilemmas arising from disclosing too much, too little, or incomplete data
- Recognize the key events leading to the adoption of disclosure regulations
- Discuss guidelines and regulations governing clinical trial disclosure
- Develop a working knowledge of the types of trials in scope of disclosure to various public registries
- Define the regulatory timelines that must be adhered to when disclosing summaries
- Predict future disclosure trends
- Discuss current compliance standings, and key contributors to lack of compliance with disclosure regulations across the industry
- Develop a working knowledge of the two most widely used public registries (ClinicalTrials.gov and the European Union Clinical Trial Register)
- Search and view study records, and access the resources and guidances available in each registry
- Manage records, user accounts, and workflow in the Protocol Registration and Results System (PRS) and the European Clinical Trials Database (EudraCT).
- Define mandatory field-level data elements, highlight specific field validations, and discuss the differences and similarities between the two
- Review source documents used in summarizing datagistration systems registration systems
- Assess criteria used to determine if a study is in scope of federal requirements
- Define the characteristics of the different types of studies that can be registered, as well as initial guidelines that should be followed when summarizing data
- Describe clinical trial protocols
- Glean data from an actual clinical trial protocol and populate an interventional protocol registration within PRS, focusing on mandatory data elements
- Define the key differences between non-interventional registrations and interventional registrations
- Glean data from excerpts from a clinical study report (CSR) and populate an interventional results summary within PRS, focusing on mandatory data elements
- Provide an overview of the international registries mandating protocol registration and results disclosure
Speaker(s)/Author(s)
Joe Archer, B Health Care Administration
Brief Bio : Mr. Joe Archer is the Associate Director, Trial Disclosure Services, and instrumental in the launch and growth of the clinical trial disclosure business at MMS. Mr. Archer has over 25 years of experience in clinical research and is a subject matter expert of processes and systems related to the reporting of clinical trial information to ClinicalTrials.gov, EudraCT, and additional registries globally. Prior to holding this role, Mr. Archer was Senior Manager, Clinical Trial Disclosures at GlaxoSmithKline from 2007 to 2011 where he led the development and oversight of systems, processes, quality controls and compliance of clinical disclosure reporting of the company’s protocol and results summary information. He has also held various positions of increasing responsibility in the Regulatory Quality Control and Strategic Operations divisions of INC Research, Pfizer, and Parke-Davis. Mr. Archer earned a Bachelor of Science degree in Health Care Administration from Eastern Michigan University. |
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Kasim McLain, BS
Brief Bio : Kasim McLain has over 15 years of experience in regulatory affairs, medical writing, and clinical trial disclosures, with 8 of those years spent specifically in disclosures. She has worked for both sponsor companies and CROs, and has successfully trained upward of 20 colleagues to be clinical disclosure leads and summary writers. Additionally, Kasim has experience with developing key disclosures process documents, implementing these processes, and conducting training programs to ensure compliance with these processes. Kasim also has a Regulatory Affairs Certification, demonstrating an overarching understanding of the regulations governing clinical drug development and a nuanced understanding of those governing clinical trial disclosures. Kasim is currently Manager of Disclosure Services at MMS Holdings, Inc. and holds a Bachelor of Science degree from Roanoke College. |
Activity Number
0864-0000-17-087-H04-T