DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)

A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.

1. DRA(Drug RegulatoryAffairs
)
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: [email protected]

2. Agenda
1.Introduction to Drug RegulatoryAffairs
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.RegulatoryBodies

3. Drug RegulatoryAffairs
It is a honest and reputedprofession.
Drug Regulatory Affairs deals with
pharmaceuticalproducts.
Ensuring compliances with regulations
and laws pertaining to theirbusiness.
Availability of safe, effective and quality
pharmaceuticalproducts.

4. Drug RegulatoryAffairs
Judge
(The CompetentAuthority)
Advocate (RAexpert)
Applicant (Thecompany)

5. Drug RegulatoryAffairs
Science
Management Legislation
Commercialization
RA
Experts

6. Why Drug RegulatoryAffairs?
Drug development and commercialization is
highlyregulated.
The path of drug registration is laid down with good
intention but canbe complicated.
Things changes……….constantly.
Somebody who gathers all relevant information in
one umbrella tobring product in the market forsell.

7. Roles of Regulatory AffairsExperts
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 inhumans.

8. 8

9. 9

10. RegulatoryBodies
India–CDSCO(CentralDrugsStandardControl
Organization)www.cdsco.nic.in/
UnitedKingdom–MHRA(MedicinesandHealthcare
RegulatoryAgency)http://www.mhra.gov.uk
EUROPE–EuropeanMedicines
Agencywww.ema.europa.eu/
ICH–InternationalConferenceon
Harmonizationhttp://www.ich.org/

11. Thank You !