atient registries have been gaining attention in
recent years as health care providers, payers, and
regulators have realized they can produce
real-world data that more accurately depict the
safety, quality, performance, and effectiveness of
drugs and devices.
There has been a growing movement to
raise the quality of observational...
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atient registries have been gaining attention in recent years as health care providers, payers, and regulators have realized they can produce real-world data that more accurately depict the safety, quality, performance, and effectiveness of drugs and devices. There has been a growing movement to raise the quality of observational research, including patient registries, so that it can be used for more purposes—from labeling and advertising to regulatory submissions and reimbursement decisions. Recent efforts by several groups have brought forth important guidelines and principles to develop or evaluate observational study data. While in clinical trials, the CONSORT statement1 criteria have set the bar and standardized practice. However, for observational research there is not a single definitive document, but rather a series of publications and consensus efforts that build on each other. These have included publications such as: • Guidelines for Good Pharmacoepidemiology Practices2
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GUIDELINES FOR
BIOAVAILABILITY &
BIOEQUIVALENCE STUDIES
Central Drugs Standard Control Organization,
Directorate General of Health Services,
Ministry of Health & Family Welfare,
Government of India,
New Delhi.
(March 2005)
These guidelines should be read in conjunction with Schedule Y to the Drugs and
Cosmetic Rules, GCP Guidelines...
Plus
GUIDELINES FOR BIOAVAILABILITY & BIOEQUIVALENCE STUDIES Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi. (March 2005) These guidelines should be read in conjunction with Schedule Y to the Drugs and Cosmetic Rules, GCP Guidelines issued by CDSCO, Ministry of Health and Family Welfare, GLP and the Ethical Guidelines for Biomedical research on human subjects issued by Indian Council of Medical Research. All provisions described in above documents shall appropriately apply to the conduct of bioavailability and bioequivalence studies.
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1
Ethical Guidelines for Biomedical Research
on Human Subjects
INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI
2000
TABLE OF CONTENTS
FOREWORD.
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1 Ethical Guidelines for Biomedical Research on Human Subjects INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI 2000 TABLE OF CONTENTS FOREWORD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PREFACE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . STATEMENT OF GENERAL PRINCIPLES ON ETHICAL CONSIDERATIONS INVOLVING HUMAN SUBJECTS . . . . . . . . . . . . . . . . . . ETHICAL REVIEW PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENER
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n engl j med 10.
1056/nejme0902377 1
edi t or i a l
The new engl and jour nal of medicine
The Medical Device Safety Act of 2009
Gregory D.
Curfman, M.
D.
, Stephen Morrissey, Ph.
D.
, and Jeffrey M.
Drazen, M.
D.
Patient safety is a national concern.
Major stakeholders throughout our health care system agree
that every step must be...
Plus
n engl j med 10. 1056/nejme0902377 1 edi t or i a l The new engl and jour nal of medicine The Medical Device Safety Act of 2009 Gregory D. Curfman, M. D. , Stephen Morrissey, Ph. D. , and Jeffrey M. Drazen, M. D. Patient safety is a national concern. Major stakeholders throughout our health care system agree that every step must be taken to ensure that medical interventions, used with the intention of improving patients’ health, are as safe as possible. But every medical intervention has benefits and risks. Patient safety can be ensured only when the makers of drugs and devices fully and openly disclose both the benefits and the potential adverse effects associated with an intervention. As the Institute of Medicine has made clear, medical devices and drugs need to be assessed for risks and benefits throughout their life cycles. 1 Unfortunately, one major stakeholder, the medical-device industry, has been shielded from the potential consequences of failing to adequately disclose
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Principles of Management – MGT503 VU
© Copyright Virtual University of Pakistan 1
Lesson 1.
1
HISTORICAL OVERVIEW OF MANAGEMENT
Major objective of treating “Principles of Management” in a concise, interesting, and understandable
manner will be to present management history and theory with an emphasis on the future.
Most...
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Principles of Management – MGT503 VU © Copyright Virtual University of Pakistan 1 Lesson 1. 1 HISTORICAL OVERVIEW OF MANAGEMENT Major objective of treating “Principles of Management” in a concise, interesting, and understandable manner will be to present management history and theory with an emphasis on the future. Most students will be applying the concepts learned here over a period of next many years. Another objective shall be to identify several areas where management concepts are applicable to the personal and professional goalsetting and also to apply the management skills to the challenge of managing the most difficult peer or subordinate – the one that may confront you in the mirror each morning in your professional career. In any treatment of a basic subject like this, there is little that the resource/anchor person can claim to be uniquely his own except his/her tacit knowledge and the presentation style. The write-ups from chapters of recommended text books for this cou
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH HARMONISED TRIPARTITE GUIDELINE
GUIDELINE FOR GOOD CLINICAL PRACTICE
E6(R1)
Current Step 4 version
dated 10 June 1996
(including the Post Step 4 corrections)
This Guideline has been developed by the appropriate ICH...
Plus
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
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Lectures: 32
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i
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY
WELFARE
(Department of Health)
THE DRUGS AND COSMETICS ACT
AND RULES
THE DRUGS AND COSMETICS ACT, 1940
(23 OF 1940)
(As amended up to the 30th June, 2005)
and
THE DRUGS AND COSMETICS RULES, 1945
(As amended up to the 30th June, 2005)
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