Q. No 1

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30 Νοε 2013 (πριν από 3 χρόνια και 8 μήνες)

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SMU
-
DDE
-
Assignments
-
Scheme of Evaluation




Q.

No

Criteria

Marks

Total Marks

1

What are Code of Federal Regulations (CFR) and which section of CFR pertains to foods

and
drugs? What are Manual of Policy and Procedures (MaPP)?

A

Definition of
Code of Federal Regulations (CFR)

and
mention the
section of CFR pertains to foods and drugs
.

4

10

Definition of Manual of Policy and Procedures (MaPP)

2

Explanation of
Manual of Policy and Procedures (MaPP)

4

2

Explain all the five scenarios as recommended by Mashelkar’s task force for
biopharmaceuticals.

A

Recommendations for Biopharmaceuticals from
“Mashelkar’s Task Force”

3

10

Recommended procedure for regulation of recombinant
pharma products derived from Living Modified Organisms
(LMOs).

2

Explain in brief all the five
possible scenarios

5

3

Describe the requirements for an IND application for exploratory Phase I study.

A

Definition of
exploratory IND study

2

10

Difference between
Traditional Phase 1 Approach

and
Exploratory IND Approach

4


Brief on c
ontent of IND Submissions

4


4

What is the significance of ‘immunogenicity’ in safety testing of a biosimilar product?
What
is the scope
and p
urpose of the guidelines pertaining to the quality issues of the

biosimilar
product?

A

Definition of
biosimilar product

and immunogenicity

2

10

Brief on
the significance of ‘immunogenicity’ in safety
testing of a biosimilar product

4

Discuss in brief about
scope and purpose of the guidelines
pertaining to the quality issues of the biosimilar product

4

5

Write a note on
color

additives in respect to its uses and restrictions. List basic laboratory
controls required for manufacture of cosmetics.

A

Definition of color additives with examples

2

10

Discussion on u
se
s

and
r
estrictions

of
color additives

3

Definition of cosmetics and importance of
Cosmetic Good
Manufacturing Practice Guidelines

2

List
out the
basic laboratory controls required for
manufacture of cosmetics

3

6

Enumerate functions of

a)

CDRH’s Office of Device Evaluation (ODE)

b)

CDRH's
Office of Surveillance and Biometrics (OSB)

c)

CDRH's Office of Compliance (OC)

d)

CDRH's Office of Health and Industry Programs (OHIP)

PROGRAM

MS
c

CRRA

SEMESTER

III

SUBJECT CODE & NAME

MR0020
-

Special Regulatory
Processes

BK ID

B08
50

DRIVE

SPRING 2013

MARKS

60

SMU
-
DDE
-
Assignments
-
Scheme of Evaluation


A

Definition and expansion of
CDRH

2

10

List out the
functions of

CDRH’s Office of Device
Evaluation (ODE

2

List out
the functions of CDRH's Office of Surveillance and
Biometrics (OSB)

2

List out the functions of CDRH's Office of Compliance (OC)

2

List out the functions of CDRH's Office of Health and
Industry Programs (OHIP)

2


*A
-
Answer



Note


Please provide keywords, short answer, specific terms, specific example
s

(wherever necessary)


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