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National Regulatory Authority Republic of Cuba. Dr. Lazara Martinez Muñoz Live Vaccine Meeting April 6-7 2009 WHO, Geneva. CECMED. NATIONAL REGULATORY AUTHORITY. REPUBLIC OF CUBA NRA evaluate by WHO, as part of process of prequalification of vaccines AENOR Quality Certificate.

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national regulatory authority republic of cuba

National Regulatory Authority Republic of Cuba

Dr. Lazara Martinez Muñoz

Live Vaccine Meeting April 6-7 2009

WHO, Geneva

slide2

CECMED. NATIONAL REGULATORY AUTHORITY. REPUBLIC OF CUBA

NRA evaluate by WHO, as part of process of prequalification of vaccines

AENOR Quality Certificate

nra of republic of cuba all functions on vaccines
NRA of Republic of Cuba . All Functions on Vaccines
  • Marketing Authorization and Licensing Activities
  • Regulatory Inspection
  • NRA Lot Release
  • Laboratory Access
  • Authorization/Approval Clinical Trials
  • Post- Marketing including surveillance of adverse events following immunization (AEFI)
slide5

Characteristic of Personnel from Biological Department:

  • 14 specialist: 1 Microbiologist, 6 Pharmacist, 2 Biochemistry and 4 Physician.
  • Master Science: 9
  • Experience at work: 6-20 years
  • Strengthening expertise and effectiveness of the NRA is achieved through training in capacity building activities, national and international courses and interchange with other NRA
  • All personal are training as internal Auditor
  • 2 specialist are member of “ Developing Countries Vaccine Regulators Network (DCVRN) 1 specialist is coordinating of PANDRH Vaccine Group and 1 specialist is member of GLP/WHO/TDR Network
  • 9 have been temporary advisers in WHO/PAHO activities
evaluation of vaccines dossier
Evaluation of Vaccines Dossier

National Guidelines, Rules and SOP WHO Guidelines on Vaccines, Others international Applicable Guidelines, Bibliographical revision

Normative Context

Peer review in Department Meeting

AS EVIDENCE

Register of evaluation for each specialist

Document of integrated results

Meetings records

COMPREHENSIVE EVALUATION OF DOSSIER

Decision

Approval

Refused

Additional Information

Revising decision at Institutional Technical Board Committee

interaction between nra and industry during r d process
Interaction between NRA and Industry during R+D process

Compulsory:

During Clinical Trials Authorization

Inspection Clinical Trials Site

Non-clinical GLP laboratories inspection

Pilot Manufacturing Plant Inspection

Marketing Authorization and Licensing

Optional

Consulting strategies of R+D

Meeting for presentations results previous to formal dossier

Consulting on CTD (Common Technical Dossier)

tb prevention and therapeutic activities
TB:Prevention and therapeutic activities
  • 100% of childbirths assisted by institutionalized qualified personnel
  • 100 % of BCG vaccination to newborn
  • National Program to detect new cases at local level (Family´s Physician):The patients' reception are performed by Physicians of the family health system and municipal policlinic
  • Control of Focus and study for diagnosis of the sick person contacts
  • Treatment controlled during at least a year by health personnel
  • 100% Salary compensation during 1 year
slide12
Non-clinical Development of Living Attenuated TB vaccines: Regulatory considerationsNon-clinical Point of View of NRA
a relevant non clinical question
A relevant non-clinical question

“How can preclinical test be better used to decide which new candidate TB vaccine will moved forward into clinical testing?”

PloSMed 4(8):e252

doi:10.1371/

journal.pmed.0040252

This question has deep regulatory implications:

Requirement of data for appropriate risk-benefit balance/methodological guidelines to aid in an efficient R+D process

slide15

First battery non-clinical studies

Phase I and II in Healthy adults

Proof of concept Reactogenicity Safety Immunogenicity Correlates of protection?

Focus: select candidate

Goal: Non inferiority to BCG Vaccine,

Identification of correlates to protection?

Immunologic, pharmacodynamic and safety studies in healthy animals comparative with BCG vaccine

Challenge: Virulent and multidrug resistant mycobacterium

Data from animals of challenge satellite groups:

Recovery alive mycobacterium

Period free of disease

Delayed Toxicity

Mice, guinea pigs and rabbits

slide16

Phase III clinical trial in healthy subjects

Confirm correlate of protection?

+Results of previous clinical trials

Second battery non-clinical studies

Risk/Benefit Balance

Focus:

Studies in outbred animals

efficiency in immunocompromised animals. Need different dose levels?

Efficacy studies in non-human primate

Goal: Protection of TB in dormant TB models and immunocompromised animals

Challenge: Virulent and multidrug resistant mycobacterium

Data from animals of challenge satellite groups:

Recovery alive mycobacterium

Period free of disease

Delayed Toxicity

Immunologic, pharmacodynamic and safety studies in immunocompromised animals and dormant latent TB animals models comparative with BCG vaccine

Behavioral after anti inflammatory therapy in vaccinated dormant TB models

slide17

Phase I/II clinical trial in immunodepressed subjects

Results of previous clinical and non-clinical studies

Third battery non-clinical studies

Risk/Benefit Balance

Focus:

efficiency in HIV animal models

Risk of IRIS

Need different dose levels or different schedule?

Goal: Protection of TB and impact of retroviral therapy

Phase I/II in HIV patients

Challenge: Virulent and multidrug resistant mycobacterium

Data from animals of challenge satellite groups:

Recovery alive mycobacterium

Period free of disease

Delayed Toxicity

“in vitro” and “in vivo” studies in HIV animals models. (SCID mice, NKO, others) Effects of vaccination

Behavioral after anti retroviral therapy in vaccinated animals

slide18

Results of previous clinical and non-clinical studies

Phase I/II clinical trial in adolescent subjects

Third battery non-clinical studies

Risk/Benefit Balance

Focus:

Risk in adolescent population

Goal: risk for fetuses

Challenge: Virulent and multidrug resistant mycobacterium

Data from animals of challenge satellite groups:

Recovery alive mycobacterium

Period free of disease

Delayed Toxicity

Studies in new born and juvenile animals and malnourished animals Evaluated risk on pregnant animals

slide19
Evaluation of all non clinical and clinical results to determine necessity to different schedule by immunological category of target population

Introducing animal vaccinated with BCG vaccine, could contribute to understand some findings

Exploratory studies in animal models for different doses and schedule

Clinical Trials Phase II to exploring dose and schedule in different target population

quality practices
Quality Practices

Usually Good Laboratory Practices are no mandatory for Pharmacological studies.

Characteristic of immunological response, TB disease and animals models require exquisite animal care, control of experiments and facilities environment

Validated animal model and methods to evaluate duration of efficient immunological and response to challenge would be required

quality practices21
Quality Practices

Quality Practices in Biomedical Research and non-clinical GLP would be mandatory to Immunological and Pharmacodynamic Studies of Candidate TB Vaccine

slide22
As NRA, we express our disposition to participate in the cooperated revision of protocols and dossiers of the TB vaccines as soon as you request it to us

Thanks for your attention