role of pharmacist in regulatory affairs

Role of Pharmacist In Regulatory Affairs

Dr. NAYYAR _UL_HASSNAINDr. RANA RIZWAN

Central Drug Laboratory Karachi27-july-2011

AIM

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 InspectorsFederal and Province drugs testing laboratoriesFederal Drug courtsPharmacy Council of Pakistan

Application Of Regulatory Affairs:Conclusion

Who Is pharmacist?

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.

What is Regulatory Affairs?


Is a unique mix of science and management toachieve a commercially important goal within adrug-development organisation.Touches everything relating to drugs from theearliest non-clinical studies, throughdevelopment, into routine manufacture andmarketing.Can add significant impact for patients and drugcompanies.


Why a discipline within its own right?

Science

Commercialisation

LegislationManagement

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

History of Regulatory Affairs?

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

Why is Regulatory Affairs Needed?Drug development and commercialization is highly regulated.The path to drug registration (Marketing Approval) is paved with good intention but can be complicatedThings change....constantly!

Why is Regulatory Affairs Needed?

Design =Development PlanCo-ordination=Writing/reviewing, supervisingConstruction=Assembling & Submission ManagementTesting=Where are the weaknesses?

Role of Pharmacist Regulatory Affairs:

Roll of pharmacist In Regulatory Affairs Department In Pharmaceutical Industries.Roll of pharmacist in Regulatory affairs through Govt. LawsFederal Govt. Provence Govt.Federal Drug Laws - Provence Drug InspectorsFederal Boards - Provence Drug LaboratoryFederal Drug Inspectors - Provence Drug courtCentral Drug Laboratory - Pharmacy CouncilsFederal Drug CourtPakistan Pharmacy Councils


Roll of pharmacist In Regulatory Affairs Department In Pharmaceutical Industries.

A Good RA Professional Pharmacist should have: 1. Good knowledge 2. Good Relation with Govt. Departments3. Decisive Diligent Authoritative4. Good Previous experience of similar problems which the company are being faced5. Ability to work with and respect other disciplines (scientific and non-scientific)6. And performance of all mater in accordance with the law is called Regularity officers


Govt. Laws That Regulate the Pharmaceutical Industries in Pakistan:

-The Drugs Act (XXXI of 1976)-The Drugs (licensing, Registering & Advertising Rules, 1976)-The drugs (federal Inspector, Federal Drug Laboratory and Federal Government Analysis) Rules 1976.-Drugs Discounts and Price Adjustment Rules 2006-The Drug (import and Export) Rules 1976.-The Pharmacy Act -The drug labeling And packing Rules. 1986-Etc


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


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.-Members of the Appellate Boards -Representatives of the Federal Govt. & Province Govt.-Chairman


Roll of pharmacist in Regulatory affairs through Govt. Laws:The Registration boards-The registration boards are responsible of drugs registration. -Chairman, secretary and members

- Refer detail examination of the drug molecule to the committee of expert. And this committee submit report before the next meeting.

- R.B sub-committee, it consisting of at least one clinical prof. one pharmacist and one pharmacist to make detailed examination of new drug molecule.

- The R.B may appoint a panel of experts or inspectors to inspects on behalf of the board of the premises of a manufacture of drugs.


Roll of pharmacist in Regulatory affairs through Govt. Laws:Federal Boards & Committee

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



Provincial Quality Control Board-Provincial government shall set up provincial quality control board consisting of members, including a chairman.-Power: - 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. analysts.-To exercise all power of inspectors-To advice the P.G on ways and means to ensure quality.-To conduct annual validation report of all instrument in the provincial drug testing laboratories-To conduct the training program to update govt. analysts for improving their knowledge .


Roll of pharmacist in Regulatory affairs through Govt. 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 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 assist in organizing and conducting the program for monitoring of the ADR.


Roll of pharmacist in Regulatory affairs through Govt. LawsCentral / Regional Drug testing Laboratories:Qualification of Federal Govt. Analysts:-Total 9 drug test laboratory are in Pakistan, in which one is Federal drug laboratory and other are provinces. -Has a degree in Pharmacy, pharmaceutical chemistry or in medicine.

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.-To carry out such other functions may be entrusted in it by the Federal Govt.


Roll of pharmacist in Regulatory affairs through Govt. Laws

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


Roll of pharmacist in Regulatory affairs through Govt. LawsPharmacy Councils of Pakistan -Total 17 member of PCP in which mostly are the pharmacist.-Total 8 member of PPC in which mostly are the pharmacist.

Functions:-To approve examination in pharmacy for the purpose of qualifying persons for registration as pharmacist.-To prescribe the subjects in which approved for exam.-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…


Application Of Regulatory Affairs:

Measure and guide line

Prevention of Hazards

Over all significance


Organization char of drug control organization of Ministry of Health

Organization Chart of Field officer of Drug control Organization.

Conclusions:

Link / Source.

http://www.dcomoh.gov.pk/about/

THANKS

role of pharmacist in regulatory affairs

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