SwissBCH

The Swiss Biosafety Clearing-House(CH-BCH): 

The Swiss Biosafety Clearing-House (CH-BCH) http://www.ch-bch.ch Swiss Agency for the Environment, Forests and Landscape (SAEFL) Albert Spielmann

The Swiss Biosafety Clearing-House(CH-BCH): 

The Swiss Biosafety Clearing-House (CH-BCH) Overview of the CH-BCH Biotechnology and biosafety in Switzerland The Swiss policy and the CH-BCH development history Description of the CH-BCH application

Swiss regulatory framework in the area of biotechnology and biosafety: 

Swiss regulatory framework in the area of biotechnology and biosafety Role of competent authorities Responsabilities and competences

Competent authorities: 

Animal Vaccines Food Biocides Seeds Feed Fertilisers Pesticides Experimental Releases Gene Therapies Medicaments Vaccines Federal Office of Agriculture Federal Office of Public Health + Swissmedic Federal Veterinary Office Swiss Agency for the Environment, Forests and Landscape Competent authorities => Based on the intended use of the LMO

Slide5: 

Coordination of enforcement SAEFL is the competent authority: field release experiments Applicant Human Health Animal Health SFOA SFOPH FVO Agriculture Environment Application Decision Statement Statement

Slide6: 

Federal Law on Non-human Gene Technology Containment Ordinance Ordinance on Transboundary Movements of GMO Federal Law on the Protection of the Environment Release Ordinance Ordinance on Accident Prevention Experts Committee Ordinance Ethics Committee Ordinance Federal Law on Epidemics

Swiss policy concerning the CH-BCH: 

Swiss policy concerning the CH-BCH Swiss political organization (Fed. State) Decentralized functions and responsibilities between Cantons, Federal Agencies and Offices Specific needs for Switzerland User and group management Workflow / Access right Multilingual support Flexibility Interoperability => Object-relational database management system

Swiss policy concerning the CH-BCH: 

Swiss policy concerning the CH-BCH 4 options Register data in the central portal using the Management centre Register data locally using database templates and send data to the central portal Make data available through a local website and allows the central portal to crawl to retrieve metadata Store data on national databases, and actively make those data available through the central portal using BCH interoperability protocols

Swiss policy concerning the CH-BCH: 

Swiss policy concerning the CH-BCH Choice of option 4: Interoperability Major reasons: Swiss political organization (Federal State): Need of a decentralized user and group management system Data are physically stored in Switzerland Security of the records Mandatory Swiss specific information can be included in new elements independent from the central BCH portal Swiss biosafety information Public awareness

The CH-BCH development history: 

The CH-BCH development history Swiss environmental data catalogue: envirocat 150 groups involved Environment relevant data, projects, documents, Internet links and resources www.envirocat.ch Swiss Clearing-House Mechanism (CH-CHM) Information platform related to biodiversity (CBD) www.ch-chm.ch => Developed using IRMI: Information and Resource Management Interface

System architecture: 

System architecture   IRMI: Based and developed using open source products only Basic software for the application Linux operating system PostgreSQL Database program ZOPE Content Management System (Python) Installation and hosting of the system Redhat and SUSE Linux Distributions Hosting at one central server (Apache) Open source components (free or very low cost)

System architecture: Client/server system: 

System architecture: Client/server system   PostgreSQL database ZOPE middleware Internet browser Client Database -> Data Bowser -> Communication Middleware -> Application Client / Server Mozilla, Firefox, Netscape, Opera, Internet-Explorer

Description of the Swiss Biosafety Clearing-House application: 

Description of the Swiss Biosafety Clearing-House application Description of the CH-BCH system General concept Utilization of elements Live demonstration Conclusion / discussion

Description of the CH-BCH application: 

Description of the CH-BCH application General concept Multi-user system Decentralized user and group management Data input controlled by: Elements with specific attributes Relationship between different element types Interaction of different roles and status Multilingual system Supports as many languages as required without changing the database Interoperability Use of common formats and exchange protocols Simple data management by multiple users having different roles Multilingual system Fully interoperable with the central BCH website

General concept: Object-relational database: 

General concept: Object-relational database Decision Law LMO Competent Authority Organization Related LMO Competent authority Contact Name Legal basis Person Person Organisation

Elements types: 

Elements types

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Role and User Authorization: 

Role and User Authorization

Status and Workflow: 

Status and Workflow

Worflow: 

Access control by role and element status Role of users Anonymous Member Author Editor Administrator Element status Open Submitted Rejected Published Expired Quality control Worflow

Decentralized management of the data: 

Decentralized management of the data Federal Office of Public Health Food Federal Veterinary Office Animal vaccines Swissmedic Gene therapies, medicaments, vaccines Federal Office of Agriculture Feed, seeds, fertilizers, pesticides Swiss Agency for the Environment, Forests and Landsacape Field releases BCH Focal point Author Author Author Author Administrator Central Database SCBD Central BCH portal

Language: 

Language Multilingual system As many languages as required No change in the database One master language (CH-BCH: English) Translations through internal functions which query an internal translation database Translation database = Datasets in database tables

Language support: workflow: 

Multilingual support Master language is English CH-BCH: 4 languages supported Language support: workflow

Utilization of elements: Anonymous functionality: 

Utilization of elements: Anonymous functionality   -> Live

Slide25: 

  Free text search Search by element types Search by owners

Slide26: 

  List of results, can be sorted by title, type,language or owner Quick overview

Slide27: 

  Available translations Help texts Direct links to additional element types Direct links to Internet resources

Conclusions: 

Conclusions Multi users system Information between many different partners Quality control Information quality controlled by role and element status Multilingual system As many languages as required Flexible system Possibility of creating new elements for specific information Interoperability Elements similar to the central BCH (common format) Fully interoperable database with the central BCH Open source components System based on open source components only Fully operational and interoperable since Jan 04

Capacity building:The CH-BCH as standard «exchange of information tool» for interested countries: 

Capacity building: The CH-BCH as standard «exchange of information tool» for interested countries Swiss Agency for the Environment, Forests and Landscape (SAEFL) Albert Spielmann

Supported transfer of the system: 

Supported transfer of the system Entire system is available Application adapted to the specific needs of the interested partner System hosted in Switzerland Technical and training support is provided Help available (hotline, e-mail) Management of data by receiving country

Supported transfer: 

Supported transfer Conditions/requirements Technical: Reliable and stable Internet connection Political: Written agreement Know-How: No special IT knowledge needed Short training course for users (1 day in Switzerland)

Supported transfer: 

Supported transfer Advantages No needs for high-tech hardware or IT knowledges Only stable Internet connection required Short training of users sufficient Disadvantages Data are physically stored in Switzerland This condition could be viewed as a starting solution At anytime, databases can be transferred back to the country of origin