Courses / Live courses

Excellence in Medical Communication Academic and Regulatory Medical Writing (24-25 April 2024)

Do you want to get the course with or without CME?

120.87 SAR
Accredited 6 CME Hours by SCFHS
Learning Activity details
Duration
Sessions 2 Sessions
Course Location: Live
Select The Most Appropriate Date To Take The Course.


Learning Activity Agenda:


Day 1

Session 1

16:00-16:30

Opening remarks

An overview of the program

Dr. Samaa AL Tabbah

Session 2

16:30-17:30

Lecture

Overview of the Clinical Research Process

Dr. Samaa AL Tabbah

Session 3

17:30-18:30

Lecture

Literature Review Basics & Techniques and Reference Management

Dr. Samaa AL Tabbah

Session 4

18:30-19:30

Lecture

Overview and Types of Medical Writing

Dr. Samaa AL Tabbah

Session 5

19:30-20:30

Lecture

Requirements and Competencies for Medical Writers

Dr. Samaa AL Tabbah

Session 6

20:30-21:30

Lecture

Basics and Techniques of Scientific Writing

Dr. Samaa AL Tabbah

Session 7

21:30-22:30

Lecture

Scientific Article Writing

Dr. Samaa AL Tabbah

22:30- 23:00

Wrap-up and closing

Wrap-up and closing

Dr. Samaa AL Tabbah

Day 2

Session 1

16:00-16:30

Opening  remarks

Review of Day 1

Dr. Nagham Ramzi

Session 2

16:30-17:30

Lecture

Introduction Regulatory Documents

Dr. Nagham Ramzi

Session 3

17:30-18:30

Lecture

Investigator's Brochure (IB) / Case Report Form

Dr. Nagham Ramzi

Session 4

18:30-19:30

Lecture

Clinical Trial Protocol write-up

Dr. Nagham Ramzi

Session 5

19:30-20:30

Lecture

Clinical Study Report write-up

Dr. Nagham Ramzi

Session 6

20:30-21:30

Lecture

Write-up of Cover letters, Consent Forms, Conflict of Interest Disclosures

Dr. Nagham Ramzi

Session 7

21:30-22:30

Lecture

Editing and Proofreading Scientific Documents

Dr. Nagham Ramzi

22:30- 23:00

Wrap-up and closing

Wrap-up and closing

Dr. Nagham Ramzi


Scientific Committee:

Target Audience:
  • Nursing and Midwifery
    1. Nursing
  • Pharmacists and Pharmacy Technicians
    1. Pharmacy
  • Health Administration and Community Health
    1. Health Administration

Learning Activity Objectives:

  - Write clear and concise medical documents, including research papers, regulatory submissions, and clinical study reports.
   - Interpret and apply specific regulatory guidelines to medical writing projects, such as FDA or EMA requirements.
   - Assess participants' writing proficiency through assignments, peer reviews, and evaluations of their ability to meet regulatory standards.
   - Measure participants' understanding of regulatory compliance through quizzes and assessments. 
 - Provide participants with access to instructional materials, templates, and samples for guidance in completing writing assignments.
   - Offer practical exercises and writing tasks to help participants develop their skills progressively.
   - Ensure that course content reflects the latest industry regulations, best practices, and ethical standards in medical writing.
   - Incorporate case studies and real-world examples that are relevant to the participants' roles and responsibilities.
   - Establish clear deadlines for assignments and assessments, allowing participants to track their progress and complete the course within a specified time frame.
   - Offer flexibility to accommodate participants' schedules while maintaining a structured course timeline.


Learning Activity Description:

Based on the assessment and gap analysis done by the scientific committee, they identified gaps as:
1. Knowledge of the regulatory requirements and guidelines for medical writing in different jurisdictions.
2. Understanding of the principles and practices of academic and regulatory medical writing, including ethical considerations.
3. Proficiency in writing clear, concise, and scientifically accurate academic and regulatory medical documents.
4. Ability to analyze and interpret complex scientific data to effectively communicate key findings in medical writing.
5. Familiarity with appropriate formatting and citation styles for academic and regulatory medical writing.


Learning Outcome:


Upon completing the course, participants should be able to:
1. Exhibit proficiency in both academic and regulatory medical writing.

2.  Apply regulatory knowledge to prepare and review documents that comply with regulatory guidelines and standards.
3. Critically analyze scientific and clinical data.

4.     Write Ethically.

5.     Manage Projects Efficiently.

6.   Collaborate effectively with interdisciplinary teams.

7.   Understand and navigate cultural differences when writing for global audiences.

8.  Incorporate feedback to improve writing skills and meet changing standards.

9. Stay informed about changes in regulations, guidelines, and industry best practices.



Certificates

You have to attend 60% of the course and fill out the survey to obtain the certificate.



Learning Activity requirements:


Testimonials

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