Pharmaceutical and clinical industry is the most regulated among all the industries. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. These standards (regulations) are set by regulatory authorities of respective countries.
Regulatory affairs [RA] is a department in the pharma industry.
- RA department is a crucial link between the company, its products and regulatory authorities.
- RA touches following studies: non-clinical studies, development, routine manufacture, testing, marketing and post-marketing stage. It thus also acts as an interface between different departments of the organisation
- RA team is involved in
- Design & development plan of product of interest
- Co-ordination = gathers data of the product from all relevant departments
- Assembling & submission of documents (DMFs/Dossiers) in-line with the current regulations to the regulatory authorities to obtain regulatory approvals.
Importance of regulatory affairs:
- For a product’s and company’s success, reduction of the time taken for a drug to reach the market is critical.
- Inadequate reporting of data/ Improper data may lead to delay of regulatory approval [as it may lead to queries and deficiencies on the drug product]
- So, RA activities should be properly conducted, as they are of economic importance.
- Product can be marketed in the country of interest only after its approval by the respective regulatory agency.
- As No DMF/Dossier = No Sale
Qualities of a good RA professional
- Good oral and written communication
- Able to apply scientific & regulatory principles
- Always willing to learn
How to keep up with the constantly changing regulatory landscape?
- Visit agency’s websites and subscribe to relevant newsletters
- Attend regulatory conferences/seminars
- Approach consultants/customers for current affairs
- Join Regulatory information databases/ authentic blogs/ private agencies publishing updates
To know more about regulatory submission procedures, IPM is the best learning platform for the last 13 years.
Institute of Pharmaceutical Management (IPM) in Mumbai endows progressive post-graduate diploma in the realm of regulatory affairs to discover positions such as Regulatory affairs associate, Regulatory affairs officer, Regulatory affairs executive, Regulatory affairs manager, to name a few. Its courses are self-paced and been intended by the industry specialists to fulfill the end-to-end requirements of tirelessly developing pharmaceutical companies and various other federal agencies.
IPM offers personalized classroom activities by way of a Tutoring Centre, Excellent Tutoring and other opportunities.