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Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3942]
Greetings to the Forum,

Following the invitation to share our thoughts I am entering the discussion at this point to endorse the comments of Luciana Ambrozelius and Andrew Roberts (along with some others) and Sol Ortiz. Sol synthesized very well:  the Manual should be used as the basis for the future alignment and the development of the integrated training package, since the manual presents more information and background. Also depending how the guidance will be modified after the testing process, it could stay as an additional document or as an integrated part of the Manual.

About decision making, we have to remember that the way to reach a decision within each competent body in each country could vary (a bit or a lot, depending on each structure of decision-making), and is influenced by public concerns and other existing bodies, so  the inclusion of such topic in the manual and or the training material could come to the point that is considered useless for those already experienced decision-makers and at the same time very complex for those not experienced ones. As mentioned by Dr Watanabe in the beginning of the discussions, it is a high risk to be incomplete and insufficient.

Thanks
posted on 2012-12-13 01:18 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3947]
I thank Dr Capalbo for starting a new thread in this discussion.

It is suggested that ‘the Manual should be used as the basis for the future alignment and the development of the integrated training package, since the manual presents more information and background’ and that the guidance document could bean ‘additional document or as an integrated part of the Manual’. I would disagree with this. The document is a training manual and it is for training, it is not a textbook on how to do a risk assessment. It is the roadmap and guidance that should be the base document and the training manual is derived from these and any other appropriate documents. Training manual should be written for the level of the audience being trained and the political and legislative environment in which risk assessment is to be conducted – a good trainer would adapt or develop new training material almost on a case-by-case basis.

As I have said in a previous posting decision making should not be included in the training manual.

Geoff Ridley
Environmental Protection Authority, New Zealand
posted on 2012-12-13 04:14 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3951]
Dear Participants,

I have read with interest the interventions thus far, and would like to contribute to this thread in our discussion.  In my view, using either the Guidance or the training manual as the standard uses the wrong baseline.  They should both be aligned with Annex III, and in the process will be aligned with each other.  This approach has the advantage of avoiding the generation of yet another document or set of documents that "a package" implies.

Hector Quemada
Donald Danforth Plant Science Center, USA
posted on 2012-12-13 09:31 UTC by Mr. Hector Quemada, Western Michigan University
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3952]
Thanks Wei , Angela . I agree with you , the guidance documents should include decision making process as one part of the package document and need also scientific proofs .
Kind regards
posted on 2012-12-13 10:29 UTC by Mr. Mahaman Gado Zaki, Niger
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3983]
I support Wei, Gado, Angela and many others on the value of having a section on decision making in the training package.

I would like also to emphasize that my understanding of the integration does not mean merging both the manual and the guidance documents to produce a single integrated document but I think they should be kept separate as parts of the training package; the manual addressing basic level and the road-map and the other guidance documents addressing more advance level. However all the components of the package need to share coherence, concepts, and interconnection and reference each other
posted on 2012-12-14 18:59 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3985]
POSTED ON BEHALF OF PATRICIA GADALETA
-------------------------------------------------------

I would like to greet to all participants and acknowledge the opportunity to participate in this forum.

I am senior scientific officer from Argentina and I am a new member on this forum. With the Director of the Biotechnology Directorate, Professor Martin Lema and other members of the Directorate, we are following the discussion with a lot of interest.

We think that the guidance document should be available to the Parties and other countries in a way that it could be adjusted or adapted for each individual country according to their capacities and policies.
In regarding to including a decision making section, we think that decision making is the obligated step that follows to the risk assessment process, but in many countries risk assessors and regulators, as well as scientific committees are usually only advisors of a competent authority who is in charge of make the final decision based not in the outcomes of the risk assessment only. If this section is included we consider that it should be wide, it should contain definitions of specifics terms related with decision making, and give examples of different types of procedures of decision making which are well established in some countries. We believe that it could be beneficial for decision makers, according the policy of each country, especially for those countries that are beginning with the design and develop of a regulatory system.

Currently, we have incorporated new professionals of different areas of knowledge to the Biotechnology Directorate and they are being trained in risk assessment, so we are thinking to test the guidance document in our Directorate for evaluating its usefulness with novice risk assessors engaged in the assessment of applications in which we are working on. And then, we will discuss the outcomes of this test to reach to a conclusion.
We will hope to be able to contribute with our experience soon.

Best regards,

Dr. Patricia Gadaleta
Biotechnology Directorate
Ministry of Agriculture, Livestock and Fisheries Argentina
posted on 2012-12-14 20:48 UTC by Dina Abdelhakim, SCBD
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3986]
Greetings to everybody,

I am new to the Forum and it is very interesting to follow this lively discussion. Regarding the section on decision making, unlike my colleague Jelena, I do believe that this should be included in the final document. I am also wondering how autonomous decisions will be made in EU member states.

Thank you and best wishes, Hrvoje Fulgosi
posted on 2012-12-14 20:49 UTC by Hrvoje Fulgosi, Croatia
RE: Forum on Risk Assessment: 3-14 December 2012 - Development of a package that aligns the Guidance with the training manual [#3990]
Dear Helmut,

seeing so many interventions on the topic proposed and many new participants wishing to share their view, I would suggest extension of the on-line forum for several days.

Thank you and best regards,
Angela
posted on 2012-12-14 22:18 UTC by Angela Lozan