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
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
Important information: The participation in this Seminar is free with limited quotas. Doesn’t include lodging and transportation costs
Must to Know
Speakers
Richard Sigman
PRINCIPAL Administrator for the Organisation for Economic Cooperation and DevelopmenT
(PARIS)
(PARIS)
Lidiane Martins de Albuquerque
representative of Inmetro in the OECD Working Group on Good Laboratory Practice
(BRAZIL)
(BRAZIL)
Schedule
Wednesday 13 February
| Time | Topic | Speaker | ||
| 8:00 | Registration of participants | National Accreditation Body of Colombia (ONAC) | ||
| 8:30 | Welcome Remarks | Richard Sigman – OECD Saúl Pineda Hoyos – Ministry of Commerce, Industry and Tourism Edgard Polanco- (SECO) Alejandro Giraldo – National Accreditation Body of Colombia (ONAC) | ||
| 9:15 | General background on OECD | Richard Sigman – OECD | ||
| 9:35 | The 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 | ||
| 10:00 | OECD Principles Good Laboratory Practice (GLP), Elements of a GLP Study | Sabrina 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 *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 MAD | Richard 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 |
Thursday 14 February
| Time | Topic | Speaker |
| 9:00 | SAFE + and its role for the implementation of the GLP roadmap of Colombia | Javier Francisco Fernandez UNIDO |
| 9:20 | GLP context Status of (GLP) compliance monitoring, receiving authorities, test facilities Current status of OECD GLP development or implementation Regulation concerning the application of OECD GLP | Richard Sigman -OECD Julia Sancricca -Argentina Lidiane Martins de Albuquerque – Brazil |
| 11:00 | Coffee 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 |
| 12:10 | Lunch break | |
| 13:30 | Nexts Step to join of MAD | All participants Julia Sancricca -Argentina |
| 14:00 | Conclusions | Alejandro 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
SPONSORS
