GIVE BREIF INTRODUCTION TO DRUG REGULATORY AFFAIRS
Comparative matrix of international regulations
23 CEC Category 15M
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comprehensive lists of emergency drugs for nurses and nursing students by Enrico Perillo Jr., RN you can copy this document at http://thenursingcorner.blogspot.comFull description
Current affairs for ESE, CSE and other UPSC aspirants for the month of January 2018.
MCQS for competitive exams in Pakistan
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MASTER OF PHARMACY M.Pharm-Drug Regulatory Affairs
Goal It is very essential for the pharmacists to have a thorough knowledge and understanding of the regula regulatory tory requireme requirement nt of pharma pharmaceu ceutica ticall indust industry ry.. Studen Students ts will will be trained trained in areas areas of CGMP !ocumentation drug discovery and development process validation GCP G"P and quality management system. #egulatory requirement for drug development product approval pre clinical and clinical trials and patent laws will be studied in detail. • •
• • • • •
CGMP !rug laws !rug discovery and development process Process validation of $PIs and finished products water sterile and non sterile facility medical devices analytical methods. Concept of %&M regulatory audits IC' Process G"P GCP Stability testing Generic drug development process (on clinical drug development Clinical trials SY!!A"#S M. Pharm $ Drug Regulatory Affairs
Phar Pharma ma(e (eut uti( i(al al Regu Regula lato tory ry Re0u Re0uir irem eme* e*ts ts
PAPER - ) Curre*t Goo+ Ma*ufa(turi*g Pra(ti(es ,(GMP a*+ Do(ume*tatio* Goals %o impart in depth study of good manufacturing practices in an industrial set up including drug laws drug discovery and development process Theory 1.
75 HOURS
cGMP of Pharmaceutical manufacturing ) *volution and Principles of cGMP Schedule+M ,'-+GMP requirements *uropean nion /*0 and nited
12 Hrs 34 Mar5s
States 1ood and !rug $dministration /S1!$0 guidelines on Pharmaceutical manufacturing. 3.
-rgani2ation and personnel responsibilities training hygiene and personal records drug industry location design construction and plant lay out
14 Hrs 34 Mar5s
maintenance sanitation environmental control utilities and maintenance of sterile areas control of contamination and Good ,arehousing Practice. 6.
Packaging of !osage 1orms3 cGMP complied packaging and documentation "abeling requirements of various regulated and non+regulated markets for
47 Hrs 14 Mar5s
%ablets Capsules "iquid -rals Parenterals4 In5ectables and Semisolids. 8.
*quipments selection 6 purchase specifications maintenance clean in place purchase specifications and maintenance of stores for raw materials.
2.
In process quality control and finished products quality control for following formulation in Pharma industry3 tablets capsules ointments suppositories
47 Hrs 14 Mar5s
14 Hrs 14 Mar5s
creams parenterals ophthalmic and surgical products. 7.
!ocumentation in pharmaceutical industry3 7atch 1ormula #ecord Master 1ormula #ecord !istribution records. Common %echnical !ocument and !rug
14 Hrs 14 Mar5s
Master 1iles. Medical !evices *lectronic Common %echnical !ocumentation 9.
$n introductory study of following laws with regard to drug product design manufacture and distribution in India / :ith latest ame*+me*ts0 3 a. !rugs and Cosmetics $ct 89:; and its rules 89:< b. (ational Pharmaceutical Pricing $uthority /(PP$0 c. %he *nvironmental Protection $ct+89=> 6 -ccupational Safety and 'ealth $dministration /-S'$0 d. Consumer Protection $ct+89=> e. 1actories $ct+89:= and Pollution control $ct+89=9 f. "aw of Contracts /Indian contract $ct+8=?@0 g. Monopolistic 6 #estrictive %rade Practices $ct+89>9 h. "aw of %orts i. Pharmaceutical inspection convention guide for cGMP
14 Hrs 14 Mar5s
;.
!rug discovery and development process3 Principles of !rug discovery and development. Clinical research process. !evelopment and informational content for Investigational (ew !rugs $pplication /I(!0 (ew !rug $pplication /(!$0 handling of -range book $bbreviated (ew !rug $pplication /$(!$0 Supplemental (ew !rug $pplication /S(!$0 Scale p Post approval changes /SP$C0 and 7ulk active chemical Post approval
4; Hrs 34 Mar5s
changes /7$CP$C0. Post marketing surveillance Current 7iopharmaceutical regulations and in particular related to Cell %herapy and regenerative medicine. RECOMME
8.
Good Manufacturing Practice #ationale and compliance by Aohn Sharp
@. Pharmaceutical master validation plan3 %he ultimate guide to 1!$ GMP and G"P Compliance by Syed Imitia2 'aider B. Pharmaceutical dosage forms3 Parenterals ol+@ II *dition by Denneth *$ and "eon "achman :.
Packaging and Pharmaceuticals and health care products by '. "ockhart 1rank $. Paine
<. %he process of new drug discovery and development. I and II *dition by Charles G. Smith Aames % and -. !onnell. >.
*stablishing a CGMP laboratory audit system+ $ Practical guide by !avid M. 7liesner.
?.
A.1.'anlon3 'and book of package engineering 3Mac+Grawhill company
=. Good manufacturing practices3 $ plan total quality control3 S.'.,ilhing M.M. %uckerman S.'itchings Marcel !eckker Inc. Eew york. 9. Cell therapy CGMP 1acilities and Manufacturing Springer
PRACT)CA!S
,7 Hours %er :ee5
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al as%e(ts li5e 8. Do(ume*tatio* for in process and finished products &uality control tests for Solid Semisolid and Sterile preparations.
@. Proto(ol preparation for purchase of manufacturing equipments and raw materials. B. Proto(ol preparation for documentation of various types of records / 71# M1# !# etc.0 :. !a&eli*g comparison between brand 6 generics. /#eview of Promotion Materials0
PAPER - )) Pharma(euti(al ali+atio*
+
Goals To +e>elo% (om%ete*(y i* i*ter*atio*al gui+eli*es i* the area of >ali+atio* metho+s? %ro(esses? e0ui%me*ts et(. THEORY 1.
3.
24 HO#RS
$n Introduction to the 7asic Concepts of Process alidation 6 'ow it !iffers from &ualification /Installation &ualification /I&0 -perational &ualification /-&0 6 Performance &ualification /P&0 Procedures alidation master plan /MP0 $ #eview of Prospective Concurrent #etrospective alidation 6 #evalidation including the use of Statistical Process Control /SPC0
HA
49 Hrs 14 Mar5s
48 Hrs 14 Mar5s
3.8 6.
8.
2.
Planning 6 Managing a alidation Program including Change Control Scale+p and Post+$pproval Changes /SP$C0 Pre $pproval Inspections /P$I0 6 %echnology %ransfer Issues alidation of ,ater /!emineralised !istilled and ,ater for In5ection0 6 %hermal Systems including 'eat entilation and $ir conditioning /'$C0 1acilities 6 Cleaning alidation Process alidation of $ctive Pharmaceutical Ingredients /$PIs0 and finished products.
4; Hrs 34 Mar5s
46 Hrs 14 Mar5s
49 Hrs 14 Mar5s
!ata generation and storage quality control documents retention samples records and audits of quality control facilities. 1inished products release quality review quality audits batch release document 7.
34 Mar5s
9.
46 Hrs
Medical !evice In Vitro !iagnostics 6 Packaging alidation Issues
14 Mar5s
;.
International
14 Hrs
Conference on 'armoni2ation /IC'0 and ,orld 'ealth -rgani2ation /,'-0
34 Mar5s
alidation
of
$nalytical
Methods
$utomated
Systems
Guidelines for calibration of equipments alidation of process3 miFing granulation drying compression filtration filling alidation of sterili2ation methods and equipments3 dry heat sterili2ation autoclaving membrane filtration. alidation of analytical procedures alidation of air handling equipments and facilities in sterile and non sterile areas.
J .K
4; Hrs
alidation of Sterile and (on+Sterile 1acility
I
+ 3 +
RECOMME
8. Pharmaceutical Process alidation? Brd *dition *dited by #obert (ash and $lfred ,achter Marcel !ekker @. Good Manufacturing Practices for Pharmaceuticals3 $ Plan for %otal &uality Control from Manufacturer to Consumer Sidney A. ,illig Marcel !ekker
PRACT)CA!S ,7 Hours %er :ee5 T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al as%e(ts li5e Preparation of protocols on various validation requirements • alidation of machines 6 analytical instruments used for Pharmaceutical formulations. • Process alidation of various pharmaceutical dosage forms. • alidation of medical devices./ vi2. (ebuli2ers Inhalers Infusion pump Insulin pens0 • Cleaning alidation • $nalytical methods alidation •
PAPER $ ))) /uality Ma*ageme*t systems Goals
"earning the system of quality audit regulatory requirements quality evaluation G"P GCP concepts etc. THEORY
24 HO#RS
1.
Concept of &uality %otal &uality Management. &uality by design siF sigma concept
;> 'rs 8; Marks
3.
$uditors $uditing strategies and preparation of audits &uality audit 6 audit check lists and $uditing of manufacturing facilities by International regulatory agencies. Conducting and 'andling of internal4!omestic4International #egulatory $udits4 Customer specific audits 4Pre approval inspections
;? 'rs 8; Marks
6.
'armoni2ation of regulatory requirements+%he International Conference on 'armoni2ation /IC'0 process guidelines to establish quality safety and efficacy of drug substances and products. Study of IC' common technical documents harmoni2ation of pharmacopoeial standards %he International -rgani2ation for Standardi2ation /IS-0 9;;; series of quality systems standards IS- 8:;;;
8; 'rs @; Marks
8.
&uality evaluation and batch release3 Change Control !eviation+/planned and unplanned0 Corrective $ction and Preventive $ction /C$P$0 'andling of non+ conformance endor evaluation process -ut of specification /--S0 batch reconciliation and finished goods release Market recalls 6 Market complaints.
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2.
Good "aboratory Practices /G"P03 Scope of G"P &uality assurance unit Standard operating procedures /S-P0 protocols for conduct of non clinical testing control on animal house report preparation and documentation.
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7.
(ational $ccreditation 7oard for testing and Calibration "aboratory /($7"0 certification and accreditation procedure
;B 'rs 8; Marks
9.
Stability testing3 IC' and ,'- guidelines Photostability studies
;.
Good Clinical Practices /GCP03 International regulatory requirements for pharmaceutical development regarding clinical research practices. Current issues in GCPH standards for design conduct performance monitoring auditing recording analysis and reporting of clinical trials. Schedule E of Indian !rugs and Cosmetics $ct 89:; #ole of #egulatory affairs in Product development Clinical phase Preclinical Phase Manufacturing phase and Marketing Phase. Indian Council of Medical #esearch /ICM#0 Guidelines for *thics in 7iomedical #esearch.
;? 'rs 8; Marks ;> 'rs @; Marks
RECOMME
8. &uality planning and $nalysis by AM Auran and 1M Gryna %ata McGraw'ill+ India. @. %otal &uality Management !ale '. 7esterfield Pearson *ducation Brd *d. @;;B. B. %otal &uality Management Principles Implementation 6 Cases Sharma !.!. Sultan Chand 6 Sons (ew !elhi @;;;. :. 1undamentals of %otal &uality Management Process $nalysis and Improvement by Aens.A !aulgard Dai Driestensen and Gopal D.Dan5i. %aylor and 1rancis <. %otal &uality Management -rgani2ation and Strategy Aames #. *vans %homson :th *d. @;;?. >. &uality Control 7esterfield !.'. Pearson ?th *d. @;;:. ?. Implementing IS- 8:;;;3 a practical comprehensive guide to the IS- 8:;;; environmental management standards $uthors3 %om %ibor Ira 1eldman *ditors3 %om %ibor Ira 1eldman Irwin Professional Pub. 899?. =. *stablishing $ cGMP "abH $udit System+ $ practical guide !avid M.7leisner ,iley Interscience. 9. %he managers guide to IS- 9;;; Denneth ". $rnold 1ree Press 899:. 8;. 'ow %o Practice G"P Good "aboratory Practice Sharma PP andana Publications 88. G"P *ssentials3 $ Concise Guide to Good "aboratory Practice Second *dition Milton $. $nderson Informa 'ealthcare. 8@. G"P &uality $udit Manual Milton $. $nderson %hird *dition Informa 'ealthcare. 8B. "aboratory $uditing for &uality and #egulatory Compliance by !onald C.Singer Stefan and Stedan !rugs and Pharmaceutical Sciences ol.8<; 8:. 'andbook of Stability %esting in Pharmaceutical !evelopment3 #egulations Methodologies and 7est Practices 'uynh+7a Dim Springer. 8<. International Stability %esting Ma22o A. Ma22o !avid A. Ma22o Informa 'ealthcare Pharmaceutical Stability %esting %o Support Global Markets /biotechnology3 Pharmaceutical $spects0 Dim 'uynh+ba Springer. 8>. Good "aboratory Practice #egulations %hird *dition #evised and *Fpanded *dited by Sandy ,einberg 8?. 'andbook of Stability %esting in Pharmaceutical !evelopment3 #egulations Methodologies and 7est Practices Dim 'uynh+ba Springer. 8=. Good Clinical Practice3 Standard -perating Procedures for Clinical #esearchers ,iley. 89. "aboratory $uditing for quality and regulatory compliance !onald C. Singer %aylor and 1rancis. @;. Current Good Manufacturing Practices M$ Potdhar 7S Publications. PRACT)CA!S ,7 Hours %er :ee5 T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al as%e(ts li5e 8. Preparation of S-Ps for various equipments and manufacturing processes as per ISrequirements. @. &uality control tests on Solid liquid semisolid and sterile dosage forms B. $ccelerated and Photostability studies on dosage forms as per IC' Guidelines :. Preparation of final clinical trial report /Phase III and III0 for submission to regulatory authorities. <. !ocumentation for audits and inspection of manufacturing facilities. >. #eport preparation of G"P for non+clinical testing
PAPER $ ) Pharma(euti(al Regulatory Re0uireme*ts Goals %o develop competency in product development regulatory requirement for product approval 1!$ regulations and guidelines preclinical and clinical trial regulations and requirements. THEORY 24 HO#RS
8. Generic !rug Product development3 Introduction &uality Control and &uality $ssurance /&C 6&$0 'atch+,aFman update !rug product performance+ in vitro, $(!$ #egulatory $pproval Process 7ioequivalence and !rug Product $ssessment+ in vivo, Scale up Post approval changes Post marketing surveillance -utsourcing 7ioavailability and 7ioequivalence studies to Contract #esearch organi2ations. 1ormats for marketing authori2ation submission to S * $sia+P$C /includes countries of *ast $sia southeast $sia $ustralasia -ceania0 etc. !ata privacy Protection and Intellectual property patents Pharmaceutical "abeling $dvertising and Promotion #isk Management in regulatory affairs
8; 'rs @; Marks
@. #egulatory requirements for product approvals3 $ctive Pharmaceutical Ingredients 7iologics (ovel therapies special categories L -ver the counter /-%CS0 herbal medicines and 'omeopathicK obtaining (ew !rug $pplication /(!$0 $bbreviated (ew !rug $pplication /$(!$0for generic drugs ways and means of S #egistration for foreign drugs Chemistry Manufacturing and controls /CMC0 Post approval #egulatory affairs #egulation for combination products /Controlled release systems0 medical device *nvironmental concerns and regulations
;= 'rs @; Marks
@8 Code of 1ederal #egulations /C1#0 Part 88 and "IMS /"aboratory information Management System0. B. 1!$ $pprovable indications and other considerations3 !ata procession for Global submission %eFt and %abular eFposition+ Common %echnical !ocument /C%!04 electronic Common %echnical !ocument /eC%!0 1ormat working with contract #esearch -rgani2ation /C#-0 Industry and 1!$ "iaison #ole of *uropean Commission Competent $uthorities and (otified 7odies and S1!$ $uthorities
;= 'rs @; Marks
:. (onclinical drug development3 Global submission of Investigational (ew !rug application /I(!0 (ew !rug application /(!$0 $bbreviated (ew !rug $pplication /$(!$0 Investigation medicinal product !ossier /IMP!0 6 Investigator 7rochure /I70 (ew product $pplications for Global Pharmaceutical Product approvals S (!$ vs Global C%! 1ormats $(!$ 6 Supplemental $bbreviated (ew !rug $pplication /S(!$0 C%! and eC%! for registration of pharmaceuticals for 'uman use combination products /Controlled release systems0. <. Clinical trials3 !eveloping clinical trial protocols Institutional #eview 7oard4 Independent *thics committee+formation and working procedures Informed consent+process and procedures 'IP$$+ $ new requirement to clinical study process Code of 1ederal #egulations /C1#04 International Conference on 'armoni2ation /IC'04* GCP obligations of Investigators sponsors 6 Monitors Importance of &uality $ssurance in clinical trials Managing and Monitoring clinical trials *uropean clinical trials /C%0 directives+ implementation and update. Pharmacovigilance+safety monitoring in clinical
;= 'rs @; Marks
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trials. >. International legal consideration3 7$ /7ureau of eFport administration0 *$# /*Fport administration regulation0 *CC( /*Fport control classification number0 S%*"$ /System for tracking eFport license application0 1CP$ /1ederal corrupt practice act0 *P$ /*nvironmental protection agency regulation0 S1! /Securities 6 eFchange commission0.
;='rs 8; Marks
RECOMME. 1!$ regulatory affairs 3 a guide for prescription drugs medical devices and biologics 4edited by !ouglas A. Pisano !avid Mantus. ?. Clinical %rials and 'uman #esearch3 $ Practical Guide to #egulatory Compliance 7y 1ay $. #o2ovsky and #odney D. $dams =. 'IP$$ and 'uman Sub5ects #esearch3 $ &uestion and $nswer #eference Guide 7y Mark 7arnes A! ""M and Aennifer Dulynych A! Ph! 9. Principles and Practices of Clinical #esearch Second *dition *dited by Aohn I. Gallin and 1rederick P. -gnibene 8;. !rugs3 1rom !iscovery to $pproval Second *dition 7y #ick (g 88. (ew !rug !evelopment3 $ #egulatory -verview *ighth *dition 7y Mark Mathieu 8@. Pharmaceutical #isk Management 7y Aeffrey *. 1etterman ,ayne ". Pines and Gary '. Slatko 8B. Preparation and Maintenance of the I(! $pplication in eC%! 1ormat 7y ,illiam D. Sietsema 8:. Medical !evice !evelopment3 $ #egulatory -verview 7y Aonathan S. Dahan 8<. Medical Product #egulatory $ffairs3 Pharmaceuticals !iagnostics Medical !evices7y Aohn A. %obin and Gary ,alsh PRACT)CA!S
,7 Hours %er :ee5
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al as%e(ts li5e •
•
• • • • • •
Preparation of regulatory compliance checklist tabulating cGMP requirements as per @8 C1# @8; and @88. Preparation of global list of documents for registration of I(! (!$ $(!$ as per IC' C%! format. Preparation of $nnual report for regulatory on approved $(!$ Case studies on response with scientific rationale to S1!$ ,arning "etter Preparation of an IMP! for * submission. Preparation of a Clinical %rial Protocol for submission to #egulatory. Preparation of regulatory compliance requirements for 7$47* study. Preparation and documentation for Indian Patent.
• • • • •
•
•
•
Patent challenge 4 non infringement /Para I0 case studies. Preparation of $nnual Product &uality #eview /$P. Preparation of Periodic Safety pdate #eport /PS#0. Comparison of key GMP requirements of India S * and Aapan of a dosage form. Comparison of Clinical %rial $pplication #equirements of India S * and Aapan of a dosage form. 1ast track approval in different countries considering different class of drugs /e.g. $nti 'I and anticancer0 therapeutic area /rare diseases0 etc. $nnotated side by side comparison of labels Prescribing Information and Patient Information "eaflet. Preparation of generic product registration application as per $ssociation of South *ast $sian (ations L$S*$(K C%! /$C%!0
Preparation of a marketing authori2ation application for -%C homeopathic and 'erbal Medicinal Product.