Dr. NAYYAR _UL_HASSNAIN Dr.

RANA RIZWAN
Central Drug Laboratory Karachi 27-july-2011

Who is pharmacist? What is Regulatory Affairs? Why is Regulatory Affairs Needed? Roll of pharmacist In R.F Department In Pharmaceutical Industries. Roll of pharmacist in Regulatory affairs through Govt. Laws: Federal Boards & committee -Appellate Boards -The Registration boards -The Central Licensing boards -Provincial Quality Control Board -Expert Committees Federal Drug Inspectors Federal and Province drugs testing laboratories Federal Drug courts Pharmacy Council of Pakistan Application Of Regulatory Affairs: Conclusion

Pharmacists are health professionals. . who practice pharmacy. Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Pharmacists typically take an order for medicines from a physician in the form of a medical prescription and dispense the medication to the patient.

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through development. Can add significant impact for patients and drug companies. into routine manufacture and marketing.Is a unique mix of science and management to achieve a commercially important goal within a drug-development organisation. . Touches everything relating to drugs from the earliest non-clinical studies.

Why a discipline within its own right? Science Management Legislation Commercialisation .

like pharmaceuticals industry. getting license and registration of pharmaceutical products for sale and every thing. . submitting products. this field in pharmaceutical industry is dealing with all aspects of government affairs .Regulatory Affairs in pharmaceuticals (RA in pharma). also known as Government Affairs( Pharmaceutical regulatory affairs in pharmaceutical industry). Regulatory affairs departments are there in most of the regulated industries.

. The concept of regulating medicines was well established in most member countries along similar lines to the US.In 1980 the European Community (European Union) started the regulation of health care products in the member countries.

The path to drug registration (Marketing Approval) is paved with good intention but can be complicated Things change.constantly! ....Drug development and commercialization is highly regulated.

supervising Construction= Assembling & Submission Management Testing= Where are the weaknesses? .Design = Development Plan Co-ordination= Writing/reviewing.

Provence Drug Laboratory .Provence Drug Inspectors . Provence Govt.Roll of pharmacist In Regulatory Affairs Department In Pharmaceutical Industries.Provence Drug court . Roll of pharmacist in Regulatory affairs through Govt. Federal Drug Laws Federal Boards Federal Drug Inspectors Central Drug Laboratory Federal Drug Court Pakistan Pharmacy Councils .Pharmacy Councils . Laws Federal Govt.

Good Previous experience of similar problems which the company are being faced 5. Decisive Diligent Authoritative 4. Departments 3. Ability to work with and respect other disciplines (scientific and non-scientific) 6. Good knowledge 2.Roll of pharmacist In Regulatory Affairs Department In Pharmaceutical Industries. Good Relation with Govt. And performance of all mater in accordance with the law is called Regularity officers . A Good RA Professional Pharmacist should have: 1.

t l s. r l r r t l sis) l s .Govt. . r t r l li i l s. r t r ) r l . aws That in Pakistan: r r r late the Phar aceutical Industries s t (XXXI f ) s (li si . ist ri rtisi s (f r lI s t r. .r s is ts ri j st t l s r (i rt rt) l s .

Roll of pharmacist in Regulatory affairs through Govt. Laws: Federal Boards & committee -Drug Appellate Boards -The Registration boards -The Central Licensing boards -Provincial Quality Control Board -Expert Committees -Quality Control committee -Price Review Committee .etc .

& Province Govt. Laws: Federal Boards & committees Appellate Board -An appellate boards for disposal of appeals persons aggrieved by any decision of the Central Licensing Board or the Registrations Board or the Licensing Authority or a Board or Authority. -Chairman . -Members of the Appellate Boards -Representatives of the Federal Govt.Roll of pharmacist in Regulatory affairs through Govt.

. And this committee submit report before the next meeting.Roll of pharmacist in Regulatory affairs through Govt. -R.B sub-committee. -The R. one pharmacist and one pharmacist to make detailed examination of new drug molecule.B may appoint a panel of experts or inspectors to inspects on behalf of the board of the premises of a manufacture of drugs. -Chairman. secretary and members -Refer detail examination of the drug molecule to the committee of expert. Laws: he Registration boards -The registration boards are responsible of drugs registration. it consisting of at least one clinical prof.

Laws: Federal Boards & Committee he Central Licensing boards -It responsible to issue certificate of license to by way of basic manufacture. -The members of this boards also have all power of Federal and province Drug inspector of inspections. two pharmacologists. semi-basic manufacture. one pharmaceutical chemist. -This board also have power to cancel the license when they see the violation of the condition of the license.Roll of pharmacist in Regulatory affairs through Govt. . -Total 17 member of this boards: -In which one pharmacist. manufacture formulation or repacking.

-To exercise all power of inspectors -To advice the P. Laws: Provincial Quality Control Board -Provincial government shall set up provincial quality control board consisting of members.Roll of pharmacist in Regulatory affairs through Govt. . -Power: . -To conduct annual validation report of all instrument in the provincial drug testing laboratories -To conduct the training program to update govt. analysts. analysts for improving their knowledge .inspect any premises where the drug is manufactured -Conduct a report of provincial inspectors in respect of contraventions of this act and report of Govt. including a chairman.G on ways and means to ensure quality.

Laws: Federal Drug Inspectors -Qualification of FDI: (under section 3 of the drug rule 1976) Has a pharmacy degree along with experienced -Duties of FDI: -To inspect not less then twice a year. -To assist in organizing and conducting the program for monitoring of the ADR.Roll of pharmacist in Regulatory affairs through Govt. . -to take a sample of any drug -To give advice to pharmaceutical industry on technical matter pertaining the manufacture of drug or accordance with GMP with view to improve the standard of industry and quality controls of drugs -To conduct surveillance of the marketed drug of ensuring quality controls.

-To carry out such other functions may be entrusted in it by the Federal Govt. Laws Central / Regional Drug testing Laboratories: Qualification of Federal Govt. Duties: -To test and analyze the such sample of as may sent to it -To test or analyze such sample as may be sent to it by the Federal govt.Roll of pharmacist in Regulatory affairs through Govt. Analysts: -Total 9 drug test laboratory are in Pakistan. pharmaceutical chemistry or in medicine. in which one is Federal drug laboratory and other are provinces. -Has a degree in Pharmacy. .

has establish many drug courts where they are necessary : -Total 3member of the drug court which as been appoint by the govt. Laws The Drug Court: -Govt. -1 is Judge of the high court.Roll of pharmacist in Regulatory affairs through Govt. which as been the chairman -Other 2 are the expert in the field medical and pharmaceutical .

Laws Pharmacy Councils of Pakistan -Total 17 member of PCP in which mostly are the pharmacist. Functions: -To approve examination in pharmacy for the purpose of qualifying persons for registration as pharmacist.Roll of pharmacist in Regulatory affairs through Govt. -Total 8 member of PPC in which mostly are the pharmacist. -To approve course of study & practical training in pharmacy -To lay down the standard of teaching to be mentioned« -To prescribe the equipment and facilities is be made available to the students -Many others functions« . -To prescribe the subjects in which approved for exam.

Application Of Regulatory Affairs: Measure and guide line Prevention of Hazards Over all significance .

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