Scam, kidnap by South African police

Scam, kidnap by South African police

Medical Writing Institute click here

MJoTAtalks click here

Emerald Pademelon Press LLC click here

Peace Scientists click here
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Scam, kidnap by South African police

Scam, kidnap by South African police

 
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Overview of medical writing training click here

Medical Writing Institute Regulatory Documentation Certificate
All students are required to sign a confidentiality agreement and agree not to share any materials from these classes, or passwords. Pages that can be shared are public pages that are freely accessed by all and are not entered by password.
Week 1. Regulatory writing and the FDA

Over-view of careers in the pharmaceutical industry, as a health journalist, in non-profit organizations and in large for profit companies; what qualifications you need; who you need to know, what you need to do. Introduction to the 3 prongs of preparing documentation required by health industry and pharmaceutical industry clients
-  getting contracts
- preparing documents for regulatory agencies
-  writing about health, disease, drugs

Homework:
- Read guidance document
-Read clinical study report and compare it with the guidance document
- Watch videos, go to Pharmaceutical industry page and health industry jobs page
Week 4. Therapeutic area: HIV/AIDS, diabetes, Alzheimer's Disease. Resume, cover letter, phone interview, onsite interview.

Updates on protocol preparation. Clinical documents for IND click here. Clinical documents for application to market drugs and for continuing to market drugs click here

Information you need to understand clinical research on 3 diseases:
- HIV/AIDS click here
- diabetes click here
Which drugs are approved, and what information you need.

Setting up a NJ LLC company because this is required by clients click here

Presenting yourself by phone interview click here
Week 5. Common technical documents, international regulatory authorities.

ICD-10 click here

Common technical document; European, Asian regulatory authorities.

What is regulated by regulatory authorities and why.
Week 7. Protocols.
Week 8. Generics. Preparation of an ANDA.
Week 9. Preparation of CSR shell report.
Week 2. Clinical study report

What it is.
What goes into it.
Why it is prepared.
Guidance documents for clinical study reports
Types of clinical study reports for different indications
Different phases of clinical trials.
The name of a clinical study report.
Who names it
Who provides the data.
What the data look like.
Narratives.
Adverse events.
Deaths.
LOCF.
Statistics and role of statistician.
Programming.
Who signs off on the clinical study report.
Why drug manufacturers and contract research organizations prefer scientists and regulatory writers to work onsite.
How much you can expect to be paid for working on a clinical study report.

Homework:
- Read protocols pages click here
- From clinicaltrials.gov, select a clinical trial in an indication that interests you and start preparing a protocol using the WHO protocol guideline click here
Week 3. Protocols, narratives, investigator brochures, informed consent, formatting


This workshop we will be discussing documents that support clinical study reports;

working on the protocols you are preparing

working on formatting documents.


What are the purpose of these documents?

How they fit into regulating drugs?

How they are prepared?

Who prepares them?

Where do the data come from?


Formatting:

automatic table of contents,

table of figures,

table of tables.


Document mechanics click here
Week 6. Cosmetics, generics, free courses

Courses for health and science professionals wanting to learn about the international pharmaceutical industry click here

Regulation of cosmetics click here

Regulation of medical devices click here

Evolution of clinical trials click here
Week 10. Preparation of CSR from prepared protocol.
Clinical trials documentation exam.