Country: Georgia
Organization: Risalat Consultants International
Registration deadline: 02 Nov 2017
Starting date: 03 Dec 2017
Ending date: 07 Dec 2017
How to register:
Organization: Risalat Consultants International
Registration deadline: 02 Nov 2017
Starting date: 03 Dec 2017
Ending date: 07 Dec 2017
Course Objectives
- Exploring the meaning of medical writing
- Learning how to write documents that meet the company’s goals and objectives
- Understanding the importance of publishing as an essential part of therapeutic product position
- Writing an abstract or manuscript
- Creating effective data displays
- Understanding the role of the writer in producing and issuing documents
- Discussing the best ways to manage the review process
- Providing and receiving feedback in useful way
- Reaching concurrence in the review process
Who Should Attend?
- Those new to the discipline who wish to understand the scope of medical writing
- Medical writers, reviewers of medical documents
- Clinical research managers and associates
- Regulatory affairs professionals
- Project physicians and medical monitors
Course Schedule
Day 1
Getting to Know Medical Writing
- The scope of medical writing
- Effective medical writing
- The writer’s role
- Assessing the audience
- Identifying and placing key messages
Medical writing Regulation
- INDs/IDEs
- Clinical protocols and amendments, and study reports
- IBs and product labels
- NDAs/BLAs/PMAs
- Annual reports
- Product labeling
- Abstracts and posters for scientific meetings
- Manuscripts for publication in scientific journals
Day 2
The Clinical Study Report
- Using templates
- Purpose of each section
- Clarity and consistency in writing
Writing for Publication
- Publishers’ requirements for manuscripts
- Standard manuscript elements: abstract, introduction, materials and methods, results, and discussion
- Abstracts and posters for professional meetings
- Preparation, review, submission, acceptance, revision, publication
- Identifying key information and paring the language
Day 3
Controlling the Sentence
- Objectivity and tone
- Fundamentals of sentence construction
- Controlling voice for readability
- Select punctuation
Day 4
Achieving Flow and Cohesiveness
- Writing effective paragraphs
- Using transitions
- Effective data displays
- Using style guides for consistent medical writing
- Overcoming writer’s block and finding time to write
Day 5
Managing the Review Process
- Charting the process flow
- Establishing metrics for managing regulatory submissions
- Putting a disclosure process in place
- Effective review practices
- Managing disparate comments from reviewers
How to register:
Program Dates: 03 – 07 December, 2017
Registration Closes on: 2 November, 2017
Registration Assistance: ***trainings@risalatconsultants.com* or risalatconsultants@gmail.com**
Skype: *risalatconsultantsint* Viber/WhatsApp: +995555116622 or +93799797919