Loading, please wait...At the end of this course, students will have a foundation in drug development background, and will have a foundation in the requirements for writing clinical documents within a standard new drug application (NDA) submission, as well as hands on experience with some of the complex aspects of clinical data interpretation and presentation.
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
Statement of ACPE Credit will be provided upon completion of the requirements for this activity (viewing the webcast passing the final examination with a minimum score of 75%) by the approved provider, CPE Consultants LLC.
Your continuing education credits will be electronically uploaded to CPE Monitor within 48 hours. Please check your CPE Monitor account to make sure your credits were accurately reported. We encourage participants to keep a printed copy of all statements of continuing education credit.
NOTE: The home study activity is approved for 15.0 contact hours credit for Pharmacists and Pharmacy Technicians. The Learning Management System automatically combines the total hours for both target audiences.
At the end of this course, students will have a foundation in drug development background, and will have a foundation in the requirements for writing clinical documents within a standard new drug application (NDA) submission, as well as hands on experience with some of the complex aspects of clinical data interpretation and presentation.
Objectives
- Describe new drug development in the United States
- Explain what are the different types of NDA (New drug approval)
- Explain the role of clinical data in the NDA
- Explain the regulations and guidelines
- Describe how to write clinical summary
- Describe how to write clinical efficacy documents
- Describe how to write clinical safety documents
- Describe how to write clinical overview
- Explain benefit and risk section of NDA
- Describe how to write ancillary clinical documents in an NDA
- Explain how to ensure consistency across various modules of an NDA
- Explain the importance of professional interactions and communications between sponsor and client teams
Speaker(s)/Author(s)
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Amanda Beaster, PhD Basic Medical Science
Brief Bio : Dr. Amanda Beaster has over 5 years of clinical medical writing experience and 7 years of laboratory research experience including technical writing. During her graduate studies, she focused on cellular and molecular biology in the fields of microbiology and immunology. She also served as a guest lecturer. One of her key responsibilities at MMS is training and development of medical writers. This involves both 1:1 and classroom setting training, as well as creation and maintenance of training material. Her interests also lie with understanding various regional regulatory requirements. In addition, she has successfully led multiple and complex regulatory writing documents, and that experience has been applied in the MMS training programs. Her document repertoire includes, but is not limited to: • Large, complex submissions, including safety and efficacy documents • Clinical Study Protocols • Clinical Study Reports • Briefing Documents Dr. Beaster holds a Ph.D. in Basic Medical Science from the University of South Alabama College of Medicine. |
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Ranjana Sundara, MD
Brief Bio : Dr. Ranjana Sundara has nearly 5 years of clinical experience, involving a focus on Ob/Gyn, Family Medicine and Internal Medicine. Since joining MMS Holdings Inc. as a medical writer, Dr. Sundara has been a lead writer on several types of clinical documents, including Clinical Study Protocols, Clinical Study Reports (CSRs), and various regulatory submission documents (including Summary of Clinical Safety [SCS]). Dr. Sundara has authored clinical documents that span across several therapeutic areas, including infectious disease, oncology, and central nervous system disease. She has been active in the training of others and she is also a member of the American Medical Writers Association. Dr. Sundara holds an M.D. from Avalon University School of Medicine. |
Activity Number
0864-0000-17-088-H04-P
Release Date:
Nov 15, 2017
Credit Expiration Date:
Nov 15, 2017
At the end of this course, students will have a foundation in drug development background, and will have a foundation in the requirements for writing clinical documents within a standard new drug application (NDA) submission, as well as hands on experience with some of the complex aspects of clinical data interpretation and presentation.
Objectives
- Describe new drug development in the United States
- Explain what are the different types of NDA (New drug approval)
- Explain the role of clinical data in the NDA
- Explain the regulations and guidelines
- Describe how to write clinical summary
- Describe how to write clinical efficacy documents
- Describe how to write clinical safety documents
- Describe how to write clinical overview
- Explain benefit and risk section of NDA
- Describe how to write ancillary clinical documents in an NDA
- Explain how to ensure consistency across various modules of an NDA
- Explain the importance of professional interactions and communications between sponsor and client teams
Speaker(s)/Author(s)
|
Amanda Beaster, PhD Basic Medical Science
Brief Bio : Dr. Amanda Beaster has over 5 years of clinical medical writing experience and 7 years of laboratory research experience including technical writing. During her graduate studies, she focused on cellular and molecular biology in the fields of microbiology and immunology. She also served as a guest lecturer. One of her key responsibilities at MMS is training and development of medical writers. This involves both 1:1 and classroom setting training, as well as creation and maintenance of training material. Her interests also lie with understanding various regional regulatory requirements. In addition, she has successfully led multiple and complex regulatory writing documents, and that experience has been applied in the MMS training programs. Her document repertoire includes, but is not limited to: • Large, complex submissions, including safety and efficacy documents • Clinical Study Protocols • Clinical Study Reports • Briefing Documents Dr. Beaster holds a Ph.D. in Basic Medical Science from the University of South Alabama College of Medicine. |
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Ranjana Sundara, MD
Brief Bio : Dr. Ranjana Sundara has nearly 5 years of clinical experience, involving a focus on Ob/Gyn, Family Medicine and Internal Medicine. Since joining MMS Holdings Inc. as a medical writer, Dr. Sundara has been a lead writer on several types of clinical documents, including Clinical Study Protocols, Clinical Study Reports (CSRs), and various regulatory submission documents (including Summary of Clinical Safety [SCS]). Dr. Sundara has authored clinical documents that span across several therapeutic areas, including infectious disease, oncology, and central nervous system disease. She has been active in the training of others and she is also a member of the American Medical Writers Association. Dr. Sundara holds an M.D. from Avalon University School of Medicine. |
Activity Number
0864-0000-17-088-H04-T
Release Date:
Nov 15, 2017
Credit Expiration Date:
Nov 15, 2017
