The document discusses Drug Regulatory Affairs (RA), highlighting its importance in ensuring compliance with regulations for pharmaceutical products. It covers the roles and responsibilities of RA experts, the types of companies employing them, and relevant regulatory bodies across different regions. The presentation emphasizes the structured and constantly evolving nature of drug development and the critical role of RA in bringing safe and effective pharmaceuticals to market.

1. DRA(Drug Regulatory Affairs
)
Presented by:
Naman Ruhela
M.Pharm (Regulatory Affairs)
Centre of Drug Regulatory Affairs,
Amity Institute of Pharmacy, Amity University,
Sector-125, Noida (UP), INDIA
E-Mail: naman.ruhela@gmail.com

2. Agenda
1.Introduction to Drug Regulatory Affairs
2.Why Drug Regulatory Affairs ?
3.Role of Regulatory Affairs Experts
4.Types of company hiring RA
professionals
5.RA professional can get employment as.
6.Regulatory Bodies

3. Drug RegulatoryAffairs
It is a honest and reputed profession.
Drug Regulatory Affairs deals with
pharmaceutical products.
Ensuring compliances with regulations
and laws pertaining to their business.
Availability of safe, effective and quality
pharmaceutical products.

4. Drug RegulatoryAffairs
Judge
(The Competent Authority)
Advocate (RA expert)
Applicant (The company)

5. Drug RegulatoryAffairs
Science
Management Legislation
Commercialization
RA
Experts

6. Why Drug Regulatory Affairs?
Drug development and commercialization is
highly regulated.
The path of drug registration is laid down with good
intention but can be complicated.
Things changes ……….constantly.
Somebody who gathers all relevant information in
one umbrella to bring product in the market for sell.

7. Roles of Regulatory Affairs Experts
 Regulatory Affairs plays a crucial role in the
pharmaceutical industry and is involved in all stages of
drug development and also after drug approval and
marketing.
 Pharmaceutical companies use all the data accumulated
during discovery and development stages in order to
register the drug and thus market the drug.
 Throughout the development stages, pharmaceutical
companies have to abide by an array of strict rules
and guidelines in order to ensure safety and efficacy of
the drug in humans.

8. 8

9. 9

10. Regulatory Bodies
 India – CDSCO( Central Drugs Standard Control
Organization) www.cdsco.nic.in/
 United Kingdom – MHRA (Medicines and Healthcare
Regulatory Agency) http://www.mhra.gov.uk
 EUROPE – European Medicines
Agency www.ema.europa.eu/
 ICH – International Conference on
Harmonization http://www.ich.org/

11. Thank You !