February 13 and 14 of 2019, Bogotá D.C. Colombia  

I Latin America Seminar on Good Laboratory
Practices – GLP and Mutual Acceptance of Data

HOSTS

SPONSORS

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About Seminar

The Organization for Economic Cooperation and Development OECD, together with the national monitoring authority on Good Laboratory Practices of OECD in Colombia ONAC, the Ministry of Commerce, Industry and Tourism, the Ministry of Environment and Sustainable Development, and the support of UNIDO, have the honor of extending to you the invitation to the first seminar OECD / Latin America in Principles of Good Laboratory Practices (GLP) of OECD and the Mutual Acceptance of Data (MAD).

 

 

 

 

 

This seminar is open to Latin American countries interested in participating and sharing their experiences about GLP of OECD. The invited guests to this seminar are the representatives of any ministry or agency in charge (or may become) of the GLP compliance monitoring program (in some countries, accreditation bodies perform both ISO 17025-based assessments and GLP inspections), representatives of authorities responsible for chemical products assessment (i.e. those who conduct assessments of industrial chemicals), and representatives of test facilities that are now carrying out GLP, or may have an interest in doing so in the future.

 

Objetives propoused in the Seminar

 

• The OECD Secretariat, government representatives of OECD countries and those who fully adhere to the MAD system, will be able to inform government agencies and relevant test facilities in Latin American countries about GLP, GLP compliance monitoring program, the MAD system and the benefits of joining the MAD system

• Latin American countries will be able to update the OECD on the current status of test facilities that applies GLP in their countries (if applicable), as well as national requirements for testing that can be presented for regulatory review and are performed according to GLP, and the level of development of a national GLP compliance monitoring program of participating countries

• The countries of Latin America and OECD will be able to discuss the next possible steps for future cooperation in the MAD system.

GLP and MAD benefits

Protect animal life
Ensure reconstruction of data

Important information: The participation in this Seminar is free with limited quotas. Doesn’t include lodging and transportation costs

Must to Know

OECD Principles on Good Laboratory Practice
Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice
Revised Guidance for the Conduct of Laboratory Inspections and Study Audit
Guidance for the Preparation of GLP Inspection Reports

Speakers

Richard Sigman

PRINCIPAL Administrator for the Organisation for Economic Cooperation and DevelopmenT
(PARIS)

Lidiane Martins de Albuquerque

representative of Inmetro in the OECD Working Group on Good Laboratory Practice
(BRAZIL)

JULIA SANCRICCA

INTERNATIONAL GLP EXPERT
(ARGENTINA)

ANA MARÍA OCAMPO GÓMEZ

Gerente de Responsabilidad Integral Colombia

Sabrina Chavez Lemus

GLP Program Coordinator/Inspector Mexican Acreditation body (ema)

Schedule

TimeTopicSpeaker
8:00Registration of participantsNational Accreditation Body of Colombia (ONAC)
8:30Welcome RemarksRichard Sigman – OECD
Saúl Pineda Hoyos – Ministry of Commerce, Industry and Tourism
Edgard Polanco-  (SECO)
Alejandro Giraldo – National Accreditation Body of Colombia  (ONAC)
 9:15General background on OECDRichard Sigman – OECD
9:35The OECD Council Acts on Mutual Acceptance of Data (MAD) and general overview of OECD Test Guidelines and OECD Principles Good Laboratory Practice (GLP).Richard Sigman – OECD
10:00OECD Principles Good Laboratory Practice (GLP), Elements of a  GLP StudySabrina Chávez Lemus-Mexico
10:30  Coffee Break 
11:00 GLP Compliance Monitoring
OECD Requirements
How are national GLP Programmes organised and what do they include
Duties of Monitoring and Receiving Authorities
Attributes of an Inspector
Preparation, Conduct and Reporting a GLP Inspection

Sabrina Chávez Lemus Mexico 

Lidiane Martins de Albuquerque (Brazil)

 *OECD (1995), Guidance for GLP Monitoring Authorities: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice. Environment Monograph No. 110  
12:30 Lunch Break 
14:00 

Relationship and differences between the OECD Principles of GLP
and ISO/IEC 17025

*OECD (2016), No.18 OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 ENV/JM/MONO(2016)47 

 

Ana María Ocampo – Colombia

Sabrina Chávez Lemus Mexico 

15:00 Benefits of MADRichard Sigman – OECD
15:20 Process for countries to adhere to MAD and experience of recent full adherent
OECD requeriments
Richard Sigman – OECD
 Coffee Break 
 

Lessons Learned from Adherents : Specific challenges

      How are national GLP Programmes organised and what do they include
      Duties of Monitoring and Receiving Authorities
      Attributes of an Inspector
      Preparation, Conduct and Reporting a GLP Inspection
 Julia Sancrica Argentina                  Lidiane Martins de Albuquerque Brazil  
16:30 Discussion
15:00 END OF MEETING  
TimeTopicSpeaker
9:00SAFE + and its role for the implementation of the GLP roadmap of ColombiaJavier Francisco Fernandez UNIDO
9:20

GLP   context 
Backround on GLP

Status of (GLP) compliance monitoring, receiving authorities, test facilities Current status of OECD GLP development or implementation

Regulation concerning the application of OECD GLP
Test facilities

Richard Sigman -OECD
Julia Sancricca -Argentina
Lidiane Martins de
Albuquerque – Brazil
11:00Coffee Break 
11:20 How test facilities become part of a  GLP national programme

Sabrina Chávez Lemus Mexico

Julia Sancricca -Argentina

11:40 Sharing information and monitoring implementation of MAD through the OECD
Working Group on GLP 
Richard Sigman – OECD
12:10Lunch break 
13:30Nexts Step to join of MADAll participants
Julia Sancricca -Argentina
14:00ConclusionsAlejandro Giraldo – National Accreditation Body of Colombia  (ONAC)
Richard Sigman – OECD
 END OF MEETING 

EVENT VENUE

CAPITAL HOTEL
Calle 25 B # 69A -50, Bogotá D.C.

NEARBY HOTELS - LODGING

HOSTS

Contact (+571) 7427592 – (+57) 311 3680891
comunicaciones@onac.org.co

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