Drug Regulatory Affairs

Mr. Pankaj DhapadeB. Pharma, MBA (Pharmaceutical), PGDPRA

Wockhardt Ltd

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

Drug Regulatory Affairs

Any Guesses?

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.

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. (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.

Drug Regulatory Affairs

E.g. Court room scenario

Judge (The Competent Authority)

Advocate (RA expert)

Applicant (The company)

Drug Regulatory Affairs

E.g. Court room scenario

Judge (The Competent Authority)

Communication Gap

Applicant (The company)

Communication Gap

Drug Regulatory Affairs

Science

Management Legislation

Commercialization

RA RA

ExpertsExperts

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 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.

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� 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.

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..

Qualities of RA experts

Team Player Proactive

Communicative Decisive

Diligent AuthoritativeDiligent Authoritative

Commercially aware Always willing to learn

Flexible Creative

Ability to work with and respect other discipline (scientific and non-scientific)

Good IT skills

Qualities for Submission Management

� Anticipating the questions

E.g. Gap analysis, Need of additional data

� Communicating� 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

In short……..

Techno-Commercial Personality

Conclusion

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

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

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/

Thank You!!!