Exam Details
| Subject | regulatory aspects of hebbal and biologicals | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | gujarat, ahmedabad |
Question Paper
GUJARAT TECI${OLOGICAI UNryERSITY
M. Ph. II SEMESTER r EXAMtr{ATTON- SUMMER -2018
Subject Code:MRA 202T Date: 16t05t2018
Subject Name: REGULATORY ASPECTS OF HEBBAL AND BIOLOGICALS
Time: L0:30AM TO 01:30PM
Instructions:
1. Attempt any five questions.
Make suitable assumptlons wherever necessary.
3. Figures to the right indicate full marks.
Total Marlis: 80
Q.l
Differentiate Biosimilars drugs with Generic fugs.
Write a note on toxicological studibs as per CDSCO.
06
05
05
06
05
05
06
05
05
06
05
Defiue: Sponsor LR (kgal Re,presentative)
Q.2 Discuss various phases for clinical development for Biosimilars.
Discuss Good agriculfural and collection praptice for starting materials of
herbal origin as per EU.
What are TSE (Tra4smissible Spongifonn Encephalopathy)?'Write a note on
diagnostic tests to detect TSE.
.. l
Q.3 Disc.uss GuidelineC for the Scientifio Data Reqirirements for Plasma Master as
perEU.
Write general requirements forA 351(k) application forBiosimilars per
USA.
lYrite a note on Pharmco-rrrgilance stu{y as per CDSCO.
Q.4 Describe labelling and packing requirements for Biologics.
Write l note on Assessment of clinical safety and efficacy in the preparation of
EU herbal monographs for well-established and traditional herbal medicinal
products.
Discuss the Industy guidance for CharacteriVationand QUalification of Cell
Substates and Other Biological Materials Used in the Production of Viral
. Vaccines for Infectious Disease Indications as per USFDA.
Q.5 Write a note on Content of BLA @iologics License Applications).
Write briefly about Post-Market Datafor Similar Biologics.
Discuss the role and responsibilities of ISBT.
Q. 6 Discuss ICH Q5C guidelines on Quality of Biotechnological Products: Stability
Testing of Biotechnological/Biological Products.
Discuss Schedule T for GMP requirements of herbal medicine ih INDIA.
Discuss the Choice of Reference Product forBiosimjlars..
Q.7 Write a note on Principles for Development of Similar Biologics as per
06
05
05
06
05
05
06
05
05
CDSCO.
Discuss standardization and quality evaluation of herbal products.
Discuss Good Agriculfure and Colleetion Practices grrideline as per AHPA.
M. Ph. II SEMESTER r EXAMtr{ATTON- SUMMER -2018
Subject Code:MRA 202T Date: 16t05t2018
Subject Name: REGULATORY ASPECTS OF HEBBAL AND BIOLOGICALS
Time: L0:30AM TO 01:30PM
Instructions:
1. Attempt any five questions.
Make suitable assumptlons wherever necessary.
3. Figures to the right indicate full marks.
Total Marlis: 80
Q.l
Differentiate Biosimilars drugs with Generic fugs.
Write a note on toxicological studibs as per CDSCO.
06
05
05
06
05
05
06
05
05
06
05
Defiue: Sponsor LR (kgal Re,presentative)
Q.2 Discuss various phases for clinical development for Biosimilars.
Discuss Good agriculfural and collection praptice for starting materials of
herbal origin as per EU.
What are TSE (Tra4smissible Spongifonn Encephalopathy)?'Write a note on
diagnostic tests to detect TSE.
.. l
Q.3 Disc.uss GuidelineC for the Scientifio Data Reqirirements for Plasma Master as
perEU.
Write general requirements forA 351(k) application forBiosimilars per
USA.
lYrite a note on Pharmco-rrrgilance stu{y as per CDSCO.
Q.4 Describe labelling and packing requirements for Biologics.
Write l note on Assessment of clinical safety and efficacy in the preparation of
EU herbal monographs for well-established and traditional herbal medicinal
products.
Discuss the Industy guidance for CharacteriVationand QUalification of Cell
Substates and Other Biological Materials Used in the Production of Viral
. Vaccines for Infectious Disease Indications as per USFDA.
Q.5 Write a note on Content of BLA @iologics License Applications).
Write briefly about Post-Market Datafor Similar Biologics.
Discuss the role and responsibilities of ISBT.
Q. 6 Discuss ICH Q5C guidelines on Quality of Biotechnological Products: Stability
Testing of Biotechnological/Biological Products.
Discuss Schedule T for GMP requirements of herbal medicine ih INDIA.
Discuss the Choice of Reference Product forBiosimjlars..
Q.7 Write a note on Principles for Development of Similar Biologics as per
06
05
05
06
05
05
06
05
05
CDSCO.
Discuss standardization and quality evaluation of herbal products.
Discuss Good Agriculfure and Colleetion Practices grrideline as per AHPA.
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Subjects
- advanced medicinal chemistry
- advanced organic chemistry-i
- advanced organic chemistry-ii
- advanced pharmacology ii
- advanced pharmacology-i
- advances in drug delivery system
- advances in pharmacology
- applied pharmacotherapeutics - ii
- applied pharmacotherapeutics-i
- audits and regulatory compliance
- biological evaluations & clinical research
- cellular and molecular pharmacology
- clinical and hospital pharmacy
- clinical pharmacy practice
- clinical research and pharmacy practice
- clinical research and regulatory affairs
- clinical research regulations
- cosmetic and cosmeceuticals
- documentation and regulatory writing
- drug design and discovery
- drug regulation and regulatory authority
- experimental design and patents
- global regulatory requirements
- gmp, glp and validation
- good manufacturing and good laboratory practice
- good manufacturing practice and process validation
- good regulatory practices
- hazards and safety management
- industrial pharmacy practice
- modern analytical techniques
- modern pharmaceutical analysis
- novel drug delivery system part-i
- novel drug delivery system-ii
- pharm. management -ii
- pharmaceutical analysis ii
- pharmaceutical and cosmetic analysis
- pharmaceutical formulation and development
- pharmaceutical formulation development and biopharmceutics
- pharmaceutical manufacturing technology
- pharmaceutical production management & technology
- pharmaceutical regulatory affairs
- pharmacological and toxicological screening methods-i
- pharmacological and toxicological screening methods-ii
- pharmacometrics and methods of biological evaluation of drugs
- pharmacotherapeutics
- principles of biopharmaceutics& pharmacokinetics
- product development and technology transfer
- quality control & quality assurance
- quality control and quality assurance
- quality management system
- regulatory affairs - i
- regulatory affairs and new drug applications
- regulatory aspects of hebbal and biologicals
- research methodology
- validation and product development