IMPLEMENTING MEASURES IN ORDER TO HARMONISE THE PERFORMANCE OF THE PHARMACOVIGILANCE ACTIVITIES PROVIDED FOR IN DIRECTIVE 2001/83/EC AND REGULATION

(EC) NO 726/2004
It has been very interesting to read and present my comments on THE CONCEPT PAPER SUBMITTED FOR PUBLIC CONSULTATION I found the document to be much user friendly as it is written in to precise detail, so helped understanding subsequent obligation. I am submitting my comment as a private individual, but in reality I work in pharmacovigilance for a pharmaceutical company, thus working for an association and my type of association is health professionals, and manufacturers. I work for a pharmaceutical company and it falls within the EU definition of a small and mediumsized enterprise I authorize publication of my identity. If possible I would like to know how the data contributation is analysed.

Consultation item no. 2:

It would be appropriate to require the marketing authorisation holder to notify modifications to the master file to the competent authorities , along with date and signature of two authorized representative. The date and signature of two authorized representative would prevent too frequent modification (unnecessary modification).

Consultation item no. 3: Is it necessary to be more precise on potential delegation, e.g. in the case of co-marketing of products? Please comment.
Perfect No comment

Consultation item no. 4: Should a copy of the audit report be retained in the master file? Would it be appropriate to require documentation of audit schedules?
Audit schedule documentation helps to inform the case processors and the company of an upcoming audit, which helps them to prepare well for the audit. I agree with documentation of audit schedules

Consultation item no. 5: Overall, do you agree with the requirements as regards the content and maintenance of the pharmacovigilance master file? Please comment.
I agree, It is a good practice. Perfect so No comment

B. Quality systems for the performance of pharmacovigilance activities Common obligations

Six Sigma and other quality improvement technique would certainly improve establishing structures and planning integrated and consistent processes. My openion is that Audits of the quality system be performed at regular intervals, on yearly basis to enhance its effectiveness.

C. Quality systems for the performance of pharmacovigilance activities by marketing authorisation holders
12. General

Perfect
13. Resource management Perfect so No comment 14. Compliance management Perfect so No comment Consultation item no. 6: Is there a need for additional quality procedures, e.g. in relation to study reporting in accordance with Article 107p of the Directive, in relation to communication on pharmacovigilance between the marketing authorisation holder and patients/health professionals; in relation to processes for taking corrective and improvement actions or in relation to the detection of duplicates of suspected adverse reaction reports in the Eudravigilance database? Perfect 15. Record management Perfect so No comment Consultation item no. 7: Do you agree with the requirements for marketing authorisation holders? Please comment.
I agree with Marketing authorisation holders as they contribute well to the parent company in revenue generation.

D. Quality systems for the performance of pharmacovigilance activities by national competent authorities and EMA
16. General No comment 17. Resource management No comment 18. Compliance management No comment 19. Record management No comment Consultation item no. 8: Do you agree with the quality system requirements? Please comment, if appropriate separately as regards requirements for marketing authorisation holders, national authorities and EMA.
It is a must to have quality in the work of pharmacovigilance to reflect the real picture of health condition to the health authority.

E. Signal detection and risk identification

20. General Perfect 21. Changed risks/new risks Ok 22. Methodology Fine 23. Signal management procedure Good

24. Work sharing of signal management Ok Consultation item no. 9: For efficiency reasons a work sharing procedure could be appropriate for the monitoring of medicinal products or active substances contained in several medicinal product. However, do you see a risk in cumulating all tasks (for the authorisation, PSUR scrutiny and Eudravigilance monitoring) in one Member State, as thereby the benefits of parallel monitoring may be lost (peer review system)? Additionally, it may be envisaged to extend work sharing to all medicinal products (including all centrally approved products) and to appoint a lead Member State in addition to EMA (Article 28a(1)(c) of Regulation (EC) No 726/2004). Please comment.
Centralisd approach would be better to reduce cost involved, it has advantages and also disadvantages, the disadvantages can be controlled by other member states actively monitoring the activity.

25. Signal detection support Fine 26. Signal detection audit Good Consultation item no. 10: In the Commissions view the aim of this part is to establish common triggers for signal detection; to clarify the respective monitoring roles of marketing authorisation holders, national competent authorities and EMA; and to identify how signals are picked up? Are the proposed provision sufficiently clear and transparent or should they be more detailed? If so, which aspects require additional considerations and what should be required? Please comment.

F. Use of terminology
27. Use of internationally agreed terminology I agree Consultation item no. 11: Do you agree with the proposed terminology? Please comment.
I agree

28. Use of internationally agreed formats and standards Good Consultation item no. 12: Do you agree with the list of internationally agreed formats and standards? Please comment. I agree

G. Transmission and Submission requirements

29. Transmission of suspected adverse reactions Ok Consultation item no. 13: Is there additionally a need for transitional provisions as regards certain aspects of this implementing measure, especially in relation to the specifications on format and content? Please comment.
I think additional development will come ahead, for the time being format and content should be uniform through out.

Annex I Electronic submissions of suspected adverse reactions 1. Definitions It is precise and elaborate.

Consultation item no. 14: Do you agree with the proposed format and content? Please comment.
It is Perfect to agree according to me

Annex II Risk management plans 1.1. Content of the Risk Management Plan Ok 1.2. Format of the Risk Management Plan Ok Part VII: Annexes Ok 1.3. Updates of the Risk management plan Ok Consultation item no. 15: Do you agree with the proposed format and content? Please comment.
I agree

Annex III Electronic periodic safety update reports 1.1. Content of the periodic safety update reports Good 1.2. Format of the Periodic safety update reports Good Consultation item no. 16: Do you agree with the proposed format and content? Please comment. I agree Annex IV Protocols, abstracts and final study reports for the post-authorisation safety studies Ok 2. Format of the study protocol Ok 3. Format of the abstract of the final study report Ok 4. Format of the final study report Ok 5. Milestones: Planned and actual dates for the following milestones: 3O 6. Rationale and background: Fine Consultation item no. 17: Do you agree with the proposed format? Please comment. Yes, I agree, the format is good.

MAJOR AND CHRONIC DISEASES REPORT 2007 1A Foreword

Ok

1B Status of the report

Ok

Fine
Summary: Ok

1 Context and mandate

Ok

2 Activities of TFMCD projects

Ok

3 Contribution of TFMCD to ECHI indicator system and the European Health Interview/Examination Survey
Ok 3.1 Health interview/examination surveys related projects Ok

4 Mental health
Ok
GROUP DOMAIN INDICATOR Ok Health status Ok Determinants of health Ok Health systems Ok

5 Health of people with intellectual disabilities

Ok

6 Mortality related projects

Ok

7 Other disease/condition based projects

Ok

3 Atherosclerotic Cardiovascular Diseases:

Ischaemic Heart Disease and StrOke

Ok

1 Introduction
Ok

2 Health Determinants/Risk Factors

Ok

3 Ischaemic Heart Disease

Ok 3.2 Hospital discharge diagnoses Ok 3.3 Mortality OK

4 StrOke
OK

5 CVD Premature Death (20-64 years)

OK Mortality from CVD at the background of other main causes of death in 1969-2002 and prognosis for 2015, EU10 and EU15, age 20-64 (Fig. 7). OK Four different patterns in CVD mortality time trends in Europe (Fig. 8-10) Ok Annual pace of CVD mortality changes between 1990 and 2002 in Europe (Fig. 11) Ok Ratio of CVD mortality in Europe in 2002 in reference to EU15 (Figure 12) Ok

6 Conclusions
Ok Valentine's Declaration: "Every child born in the new millennium has the right to live until the age of at least 65 without suffering from avoidable cardiovascular disease. Good motivation

4 Autism Spectrum Disorders

Ok

1 Introduction
1.1 Definition of Autism Spectrum Disorders Ok 1.2 Current Health Information on Autism Spectrum Disorders Ok Surveillance of risk factors on Autism and Cerebral Palsy (ENSACP) was selected for Ok 1.3 Historical overview: important past trends/developments Ok

2 Health determinants/risk factors

Ok

3 Incidence/prevalence
3.1 Incidence Ok 3.3 Development of a European ASD prevalence estimate protocol Ok

4 Morbidity
Ok

5 Mortality
Ok

6 Other Outcomes of EAIS Project

6.1 European Autism Alliance Ok 6.2 Financial Burden of ASD Ok

65

7 Conclusion
Ok

5 CANCER
5.1 Introduction
Ok

5.2 Information: the role of cancer registries

Ok

5.3 Incidence
Ok 5.3.1 Focus on health determinants: the role of diet and physical activity Ok

5.4 Cancer Screening

Ok 5.4.1 Focus on cervical cancer screening in five European countries Ok

5.5 Survival
Ok 5.5.1 Focus on cancer diagnosis and treatment indicators Ok

5.6 Mortality
Ok

5.7 Prevalence
Ok

5.8 Cancer and wealth

Ok

5.9 Comments and conclusions

Ok 5.9.1 Focus on recommendations of EU Portuguese Presidency on cancer strategies in Europe No comments / Error free

6 Dementia
1 Introduction
No comments / Error free

2 Health determinants/risk factors

No comments / Error free

3 Prevalence and Incidence

No comments / Error free

4 Morbidity
A Hospital discharge No comments / Error free B Clinical management No comments / Error free C Treatment No comments / Error free D Survival No comments / Error free E Disability No comments / Error free

5 Mortality
No comments / Error free

6 The EUROCODE project

No comments / Error free

7 Conclusion
No comments / Error free

7 Depression
No comments / Error free

Content 1 Introduction
No comments / Error free

2 The ESEMeD Project

2.1 Scope No comments / Error free 2.2 Methods No comments / Error free

Sampling methods No comments / Error free The survey interview No comments / Error free Survey procedures and data control No comments / Error free Data weighting and analysis No comments / Error free

3 Frequency of Mood Disorders

3.1 Prevalence No comments / Error free 3.2 Comorbidity No comments / Error free 3.3 Determinants of Risk No comments / Error free 3.4 Life Expectancy Free of Mood Disorders No comments / Error free

4 Burden of mood disorders

4.1 Dysfunction and Health-Related Quality of Life No comments / Error free

5 Use of Services among those with Mood Disorders

5.1 Use of Services No comments / Error free 5.1.1 Lifetime consultation rates for mental health problems No comments / Error free 5.2 Minimally Adequate Treatment No comments / Error free

6 Suicidality
No comments / Error free

7 Conclusions
No comments / Error free

8 Diabetes
Introduction
No comments / Error free

DG SANCO Diabetes projects

No comments / Error free

1 Health determinants/risk factors

No comments / Error free 1.1 Obesity No comments / Error free 1.2 Impaired glucose tolerance/impaired fasting glucose No comments / Error free 1.3 Family history and genetic background

2 Incidence/prevalence
2.1 Incidence in children No comments / Error free 2.2 Prevalence above 25 years of age No comments / Error free

3 Morbidity
3.1 Clinical management No comments / Error free 3.1.2 Blood pressure No comments / Error free No comments / Error free 3.2 Disability No comments / Error free

4 Mortality
No comments / Error free Prevalence of dialysis/transplantation No comments / Error free

6 Conclusion
No comments / Error free

9 Haematological Malignancies
9.1 Introduction
No comments / Error free

9.2 The Relevance of Haematological Malignancies for Public Health

No comments / Error free 9.2.1 Classification of haematological malignancies, comparability of indicators No comments / Error free

9.3 Incidence and mortality

No comments / Error free 9.3.1 Incidence No comments / Error free NON HODGKIN LYMPHOMA HODGKIN S DISEASE 9.3.2 Brief review of risk factors for Haematological malignancies No comments / Error free Congenital conditions. No comments / Error free Familial predisposition. No comments / Error free Immunosuppressive drugs No comments / Error free Other health conditions. No comments / Error free Exposure to environmental agents. No comments / Error free Ionising and UV radiation. No comments / Error free Lifestyle-related risk factors. No comments / Error free

9.3.3 Mortality No comments / Error free NON HODGKIN LYMPHOMA HODGKIN S DISEASE No comments / Error free

9.4 Survival
No comments / Error free NON-HODGKIN LYMPHOMA (NHL) HODGKIN LYMPHOMA (HL) ALL LEUKAEMIAS MULTIPLE MYELOMA (MM) No comments / Error free ACUTE LYMPHTATIC LEUKAEMIA (ALL) CHRONIC LYMPHTATIC LEUKAEMIA (CLL) ACUTE MYELOID LEUKAEMIA (ALL) CHRONIC MYELOID LEUKAEMIA (CML) 9.4.1 Time trends of five and ten-year relative survival No comments / Error free 9.4.2 Focus on treatment indicators: treatment delay and compliance with guidelines No comments / Error free

9.5 Important Outcomes of the Haemacare Project

No comments / Error free

9.6 Conclusion
No comments / Error free

10 Maternal and Child Health

A Maternal and perinatal health
No comments / Error free

A Maternal and Perinatal Health 1 Introduction

1.1 Perinatal health: an overview of historical trends No comments / Error free 1.2 The EUROPERISTAT project: objectives, members and indicator set No comments / Error free

2 Population based data sources for monitoring perinatal health

2.1 Coverage No comments / Error free

3 Population characeristics and risk factors

3.1 Key indicators No comments / Error free

4 Fetal, neonatal and infant mortality and morbidity

4.1 Key indicators No comments / Error free 4.2 Measurement and methods No comments / Error free

5 Maternal mortality and morbidity

5.1 Key indicators No comments / Error free 5.2 Measurement and methods No comments / Error free 5.3 Data on incidence, prevalence and time trends No comments / Error free Maternal Mortality No comments / Error free

6 Cerebral palsy : longer term consequences of perinatal events on child health

6.1 Indicator definition No comments / Error free 6.2 Measurement and methods No comments / Error free 6.3 Data on prevalence and risk factors No comments / Error free

7 Health services provided to pregnant women and their newborns

7.1 Key indicators No comments / Error free

8 Conclusion
Fine

B Very Low Gestational Age and Very Low Birth Weight infants
Acronyms and abbreviations No comments / Error free

1 Introduction
1.1 Scope of the chapter No comments / Error free 1.2 Perinatal impact of VLGA/VLBW infants No comments / Error free 1.3 Historical overview No comments / Error free 1.4 Neonatal networking No comments / Error free

2 Health determinants/risk factors

2.1 Overview No comments / Error free 2.2 Principal risk factors and determinants No comments / Error free

3 Morbidity
3.1 Clinical management and therapies

No comments / Error free 3.1.2 Neonatal care at the NICU No comments / Error free 3.2 Major short-term morbidity No comments / Error free 3.3 Disability No comments / Error free

4 Mortality
4.1 Overview No comments / Error free

5 Health services provided to VLBW/VLGA newborn infants

5.1 Measuring quality of care and health service provision for VLBW infants No comments / Error free 5.2 Patient safety No comments / Error free

6 Conclusion
No comments / Error free

11 Multiple Sclerosis
No comments / Error free

Content
No comments / Error free 1.2 MS socio-economic burden in Europe No comments / Error free

2 Health determinants/risk factors

No comments / Error free Genetic factors No comments / Error free Environmental risk factors No comments / Error free

3 Incidence/prevalence
No comments / Error free 3.1 MS case registers in Europe No comments / Error free

4 Morbidity
No comments / Error free 4.2 Treatment No comments / Error free 4.3 Survival No comments / Error free 4.4 Disability No comments / Error free

5 Mortality
No comments / Error free

6 Objectives of the MS-ID project: No comments / Error free 7 Conclusion

No comments / Error free

12 Musculoskeletal Conditions
1 Introduction
No comments / Error free The core recommendations are: 1 Occurrence of self reported musculoskeletal pain No comments / Error free 2 Occurrence of rheumatoid arthritis No comments / Error free 3 Occurrence of osteoarthritis in hip and knee No comments / Error free 4 Occurrence of osteoporosis No comments / Error free 5 Reduced function No comments / Error free 6 Work disability No comments / Error free 7 Occurrence of hip fracture No comments / Error free 8 Hip and knee arthroplasty No comments / Error free 9 Drugs for treatment and prevention of osteoporosis No comments / Error free 10 Drugs for treatment of rheumatoid arthritis No comments / Error free

2 Health determinants/risk factors

No comments / Error free Determinants of musculoskeletal health Gender No comments / Error free Age No comments / Error free Body mass index No comments / Error free Physical activity No comments / Error free Nutrition No comments / Error free

SmOking No comments / Error free Determinants of specific musculoskeletal conditions Osteoarthritis No comments / Error free Rheumatoid Arthritis No comments / Error free Osteoporosis and fragility fracture No comments / Error free Low back pain No comments / Error free
Occurrence Chronicity Individual factors

No comments / Error free Regional pain No comments / Error free

3 Incidence/prevalence
No comments / Error free Data available No comments / Error free Musculoskeletal problems and conditions as a whole No comments / Error free Health inequalities No comments / Error free Trends No comments / Error free Osteoarthritis No comments / Error free Trends No comments / Error free Rheumatoid arthritis No comments / Error free

4 Morbidity
A Hospital discharge data No comments / Error free B Clinical management No comments / Error free C Treatment No comments / Error free Pharmacological Treatments No comments / Error free

Investigations No comments / Error free Human resources No comments / Error free

Physical resources No comments / Error free D Survival No comments / Error free E Disability and social consequences No comments / Error free

5 Mortality
No comments / Error free

6 Conclusion
No comments / Error free
Domain Indicator

No comments / Error free

Health services usage

No comments
Pharmacological treatments

No comments

13 Oral Health
No comments

1 Introduction
No comments 1.1 Oral Health strategies for Europe No comments 1.2 Oral Health Surveillance Strategies for Europe No comments

2 Determining factors / risk of health

No comments

3 Impact / predominance
No comments

4 Improving data availability for European oral health indicators

No comments

5 Conclusion
No comments

14 Sexual and Reproductive Health

1 Introduction
No comments

Health determinants / risk factors

No comments Age differences No comments Health inequalities No comments

3 Incidence / prevalence of SRH indicators

No comments

4 Morbidity
No comments

5 Conclusion
No comments

15 Life Expectancy with Chronic Morbidity

No comments

1 Introduction
No comments Background to health expectancies No comments The Euro-REVES project No comments The Statistics on Income and Living Conditions (EU-SILC) No comments

2 Health determinants/risk factors

No comments

3 Prevalence of global chronic morbidity

No comments

4 Life expectancy with chronic morbidity (LEwCM)

No comments Life expectancy at age 65 No comments Years with chronic morbidity at age 65 No comments Health inequalities No comment

3 Incidence / prevalence of SRH indicators

No comment

4 Morbidity
No comment

5 Conclusion
No comment

European Health Interview Survey (EHIS); ii) No comment

15 Life Expectancy with Chronic Morbidity

No comment

1 Introduction
No comment Background to health expectancies No comment The Euro-REVES project No comment The Statistics on Income and Living Conditions (EU-SILC) No comment

2 Health determinants/risk factors

No comment

3 Prevalence of global chronic morbidity

No comment

5 Conclusion
Ok Future initiatives Have been planned well. I agree with the view of the authors, according to me Authors have contributed good and it would be suitable for the Commission to adopt and approve the views after having a meeting with members among final authorizing commitee. When published I would like to know what specific implementing Regulation was build on this consultation. My e-mail is drsameerahmed2003@yahoo.co