This presentation covers basic understandings of regulatory affairs profession. It contains, 1. Introduction of Regulatory Affairs 2. Why Drug Regulatory Affairs 3. Role of Regulatory Affairs Experts 4. Qualities of Regulatory Affairs Expert 5. Qualities for Submission Management 6. Regulatory Bodies

1. Drug Regulatory Affairs
Mr. Pankaj Dhapade
B. Pharma, MBA (Pharmaceutical), PGDPRA
Wockhardt Ltd

2. Agenda
1. Introduction to Drug Regulatory Affairs
2. Why Drug Regulatory Affairs ?
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies

3. Drug Regulatory Affairs
Any Guesses?

8. Drug Regulatory Affairs
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.

9. Drug Regulatory Affairs
It is a dynamic and challenging field in the pharmaceutical industry.
It is an affair between the competent authority and an applicant
(company) to manage life cycle of the products.
In present regulatory scenario, company requires experts in regulatory
activities to manage the product life cycle.
RA experts are qualified professionals to provide right solution to the
technical problems under the light of laws and regulations.

10. Drug Regulatory Affairs
E.g. Court room scenario
Judge
(The Competent Authority)
Advocate (RA expert)
Applicant (The company)

11. Drug Regulatory Affairs
E.g. Court room scenario
Judge
(The Competent Authority)
Communication Gap
Applicant (The company)

12. Communication Gap

13. Drug Regulatory Affairs
Science
Management
RA
Experts
Commercialization
Legislation

14. 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.

15. 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.

16. Roles of Regulatory Affairs
In this highly regulated environment, regulatory affairs plays a critical role
not only as the interface with health agencies and as a link between different
departments in the company but also as the leading department to provide
strategic advice on extremely difficult decisions through the life of a drug.
Regulatory professionals keep working with the authorities and different
departments within the company in order to meet regulatory commitments
with the health authorities.
Regulatory experts also ensures the maintenance of the marketing licence
and leads life cycle extension activities such as broadening the indication of
the drug, change of formulation, changes in the dosage etc..

17. Qualities of RA experts
Team Player
Proactive
Communicative
Decisive
Diligent
Authoritative
Commercially aware
Always willing to learn
Flexible
Creative
Ability to work with and respect other discipline (scientific and non-scientific)
Good IT skills

18. Qualities for Submission Management
Anticipating the questions
E.g. Gap analysis, Need of additional data
Communicating
E.g. Internally – Your team, management
Externally – The assessors, experts
Controlling resources
E.g. Appropriate databank
Getting things done in the right time-frame

19. In short……..
Techno-Commercial Personality

20. Conclusion
Regulatory Affairs is a rewarding, intellectually stimulating and highly
regarded profession within pharmaceutical companies.

21. Regulatory Bodies
US - USFDA (United State Food and Drugs Administration)http://www.fda.gov/
Europe - EMA (European Medicines Agency)http://www.ema.europa.eu/ema/
Japan - MHLW-PMDA (Medicines and Pharmaceuticals Devices Agency)
http://www.mhlw.go.jp/english/
Australia - TGA (Therapeutics Goods Administration)
http://www.tga.gov.au/
Canada - TPD (Therapeutics Product Directorate)
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php

22. Regulatory Bodies
United Kingdom – MHRA (Medicines and Healthcare Regulatory Agency)
http://www.mhra.gov.uk
Ireland – IMB (Irish Medicines Board)
http://www.imb.ie/
ICH – International Conference on Harmonization
http://www.ich.org/

23. Thank You!!!