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CPE CONSULTANTS, LLC
 

The Fundamentals of Medical Writing


Being a successful medical writer requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively.

Our hands-on course for the clinical and regulatory focused individuals in the pharmaceutical industry will allow you to apply your skills to almost any regulatory document. This 12 weeks course will focus on learning how to interpret data and write standard regulatory documents. Also covered is a detailed background on the drug approval process and associated documentation.

 

  CPE Consultants LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). The Universal Activity Number (UAN) for this activity is 0864-0000-17-075-H04-P / 0864-0000-17-075-H04-T. The activity is accredited for 15.0 contact hour (1.5 CEUs). The official release date for this activity is September 25, 2017 and the expiration date is September 25, 2020.
 
NOTE:This activity has been approved for 15.0 contact hour for both pharmacists and pharmacy technicians; the learning managment system automatically calculates the total number of contact hours that have been approved by the provider for this activity.
 
A Statement of ACPE Credit will be provided upon completion of the requirements for this activity (viewing the webcast and successfully passing the posttest) by the approved provider, CPE Consultants LLC.
 
Your continuing education credits will be electronically be 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.

Fee

$0.00

CE Hours

30.00

CE Units

3.000

Activity Type

  • Knowledge

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
Accreditation Council for Pharmacy Education
 

Requirements for CE Credit

 
A 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.

 

 

   

Knowledge checks will be assessed through a quiz in every session. Evaluation of written reports will be assessed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.

Objectives

  • Describe new drug development in the United States
  • Explain how clinical trials are designed
  • List the components of a clinical trial
  • Describe clinical study protocols (CSPs)
  • Describe how to prepare and publish a protocol synopsis for regulatory submission
  • Explain the use of style guides in medical writing
  • Explain the importance of professional interactions and communications between sponsor and client teams
  • Define quality control (QC) and what happens after quality control
  • List characteristics of a quality document
  • Apply the principles of quality control to a written document
  • Provide an overview of a clinical study report including common clinical terms, drafting a CSR, types of CSRs, the role of the medical writer during drafting, typical draft cycles and associated timeliness
  • Prepare a clinical study report (CSR)
  • Describe the different career options as a medical writer and how to successfully obtain a position as a medical writer

Speaker(s)/Author(s)

Alan Hammer, Univerity of Toledo
Associate Medical Writer, MMS Holdings


Brief Bio : Dr. Alan Hammer has nearly 10 years of research experience in which he collected, analyzed, and interpreted scientific data. He spent 6 years working in preclinical research, developing an innovative method for detecting metastatic potential in breast cancer and identifying novel drug targets for cancer therapy. During this time, Dr. Hammer authored, reviewed and edited multiple peer-reviewed manuscripts and published a book chapter on the role of the hormone prolactin in breast cancer progression. Since joining MMS Holdings Inc. as a medical writer, Dr. Hammer has been lead writer on several types of clinical documents, including clinical study reports (CSRs) and various regulatory submission documents (including integrated summary of safety [ISS], summary of clinical safety [SCS], and summary of biopharmaceutics and associated analytical methods). Dr. Hammer has authored clinical documents that span across several therapeutic areas, including pain management, cardiovascular disease, and acid reflux disease. Further, he serves as a point of contact for medical and regulatory writing issues within MMS Holdings Inc. Dr. Hammer holds a doctorate in Cell and Molecular Biology from the University of Toledo and is a member of the American Medical Writers Association.

Teresa Cesena, PhD
Sr Manager Regulatory & Medical Writing, MMS Holdings


Brief Bio : Dr. Teresa Ceseña has over 10 years of pharmaceutical writing experience, and now leads the medical writing department as Senior manager of medical and regulatory writing since 2009. The medical writing team has grown significantly, and one of her key responsibilities has been to ensure that onboarding, training and mentoring continue to maintain high levels of quality. Before coming to MMS, she had also taught at the university level. As one of her key responsibilities is training of new medical writing colleagues, Dr. Cesena is responsible for implementing and maintaining processes and training programs. This includes establishing training exercises, other training material, and the development and training of mentors. Other responsibilities include developing training material for clients. 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 • Lay summaries • Briefing Documents • Writing and submitting grants, including facilitating grant writing workshops Education: University of Michigan, University of New Mexico

Activity Number

0864-0000-17-075-H04-P

Release Date: Sep 25, 2017
Credit Expiration Date: Sep 25, 2020

   

   

Objectives

  • Describe new drug development in the United States
  • Explain how clinical trials are designed
  • List the components of a clinical trial
  • Describe clinical study protocols (CSPs)
  • Describe how to prepare and publish a protocol synopsis for regulatory submission
  • Explain the use of style guides in medical writing
  • Explain the importance of professional interactions and communications between sponsor and client teams
  • Define quality control (QC) and what happens after quality control
  • List characteristics of a quality document
  • Apply the principles of quality control to a written document
  • Provide an overview of a clinical study report including common clinical terms, drafting a CSR, types of CSRs, the role of the medical writer during drafting, typical draft cycles and associated timeliness
  • Prepare a clinical study report (CSR)
  • Describe the different career options as a medical writer and how to successfully obtain a position as a medical writer

Speaker(s)/Author(s)

Howard Kenna
CHI

Teresa Cesena, PhD
Sr Manager Regulatory & Medical Writing, MMS Holdings


Brief Bio : Dr. Teresa Ceseña has over 10 years of pharmaceutical writing experience, and now leads the medical writing department as Senior manager of medical and regulatory writing since 2009. The medical writing team has grown significantly, and one of her key responsibilities has been to ensure that onboarding, training and mentoring continue to maintain high levels of quality. Before coming to MMS, she had also taught at the university level. As one of her key responsibilities is training of new medical writing colleagues, Dr. Cesena is responsible for implementing and maintaining processes and training programs. This includes establishing training exercises, other training material, and the development and training of mentors. Other responsibilities include developing training material for clients. 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 • Lay summaries • Briefing Documents • Writing and submitting grants, including facilitating grant writing workshops Education: University of Michigan, University of New Mexico

Activity Number

0864-0000-17-075-H04-T

Release Date: Sep 25, 2017
Credit Expiration Date: Sep 25, 2020