Clinical data management and drug regulatory affairs

Hello Everyone ,

Hope you all are doing well

let’s discuss about the Clinical data Management Vs Drug regulatory affairs.

Q. How you build the career out of it ?

Q. What  is difference between both of the domains ?

Q. Which the best career for you ?

If you are fresher then this is most helpful to you

First you know about the clinical data management .

Clinical data management mean’s managing the data which data clinical trial data. that means collecting the data  of the clinical trial and validate it accordingly to the guidelines ..ICGCP you can say .

There are different principal 

13 principal in good clinical practices and  ICH has 4 different guidelines you need to know specially safety guidelines you need to know.

This is about the clinical data management

So , here about the Drug regulatory affairs .

Q. What is drug regulatory affairs ?

Ans-       It is nothing but the connecting link between the regulatory authority of a respective country and manufacturing company .

any approval need to get for any manufacturing compony for domestic sale of the international export then you need to prepare the document and submit to the regulatory authority and get the approval . this kind of procedure can be done by the regulatory affairs professional and this are called the drug regulatory affairs , training or officer .

Q. What are the Job description in clinical data management and drug regulatory affairs ?

Ans-      So about the clinical data management the job description

• Produce accurate data from the complex data–   the data from the clinical trial are some or complex you have to prepare it properly and submit to regulatory authority
• Database lock–  whatever the data is a confidential data of patient you have to protect it.

And in drug regulatory affairs 

to produce quality documentation which is required to submit in regulatory authority because on the basis on the documentation and description  they are approval the products for in domestic and international

You have been involve in drug development process where any clinical trials are completed for the approval of the next clinical trial regulatory affaires professional are needed to submit the documentation previously trial and get the approval for next trial.

If any project is arises then you need to know about the guidelines 

• prepare the document
• submit to the higher authority
• take the follow up
• You have to update the guideline ICH

Quality guideline are majorly use in Drug regulatory affairs and safety guideline are used in clinical data management.

• Skills required  in clinical data management

1. clinical trial information
2. different operation
3. clinical data management phases

• Technical skill 

1. oracle
2. Rave
3. medical data

Skill required in Drug Regulatory affairs

1. legal framework
2. strong analytical skill
3. project management skill
4. excellent communication ability

Q. Where did you get the job in clinical data management ?

1. contract research organization
2. pharmaceutical companies
3. IT consulting firms

In DRA-

1. corporate offices
2. biotechnology firms
3. medical device companies

Salary

cdm-2.8 to 3.6 LPA

dra-1.8 to 3.6 LPA

Courses-

certification courses in DRA and CDM

You can join our 3 month certification course in Clinical Data Management and Drug regulatory affairs . here we will teach you all the operation.

We also improve your soft skill development and we also provide 100 % placement assistance .

For More information about the certification course kindly call us  on 9322341947

If you want know about us then visit us on

Web link

www.globalpharmaacademy.com

We are also available on mobile application…download from following links to get in touch with us

Here are link

https://play.google.com/store/apps/details?id=co.learnol.bnocb&pli=1

IOS link

https://apps.apple.com/in/app/classplus/id132452226

THANK YOU.