-Challenges for the CSL/Pfizer Animal Ethics Committee John Phelps CSL Biotherapies Meeting Animal...
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Transcript of -Challenges for the CSL/Pfizer Animal Ethics Committee John Phelps CSL Biotherapies Meeting Animal...
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- Challenges for the CSL/Pfizer Challenges for the CSL/Pfizer Animal Ethics CommitteeAnimal Ethics Committee
John PhelpsJohn Phelps
CSL BiotherapiesCSL Biotherapies
Meeting Animal Welfare Meeting Animal Welfare Needs in a Biotherapies Needs in a Biotherapies
EnvironmentEnvironment
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Scope of Activities
Human (CSL) & Animal (Pfizer) Biotherapies
Vaccines Antiserum products Recombinant Biologicals
40:40 (New: Ext) Applications Year Quality Control Testing of Therapeutic
Products Production of Biological materials R&D of New Vaccines & Biotherapies
Animal Facilities Laboratory animals
Mice/Guinea Pigs/Rabbits/Ferrets Housed animals
Dogs/Cats/Poultry/Pigs Livestock
Cattle/Sheep/Horses
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AEC Membership
Serving the AEC needs of 2 institutions confidentiality requirements of internal members differences in lines of company reporting maintaining balanced AEC membership
Recruitment availability of C & D Categories identifying potential members selection of the right members
Maintenance site inductions and car parking workloads at critical times work hour incompatibility communications & conferencing limited need for conflict resolution
Science vs Animal Welfare discussions if the science isn’t right, animals will be wasted scientific vs lay language in applications
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Meeting all Regulatory Codes
Pharmacopeia requirements vs test refinement test procedures must follow compendial methods recognition of invention points is critical test alternatives are being introduced
Quarantine restrictions - animal care and fate physical containment vs environmental enrichment approved disposal method vs animal fate
Environmental codes vs cage enrichment waste management codes - animal exercise areas effluent codes and cage washing methods air change rates may affect global warming!
Interstate projects - regulatory differences differences in site licence conditions
Codes are often complementary e.g. requirements for animal welfare reinforced in
major biotherapy manufacturing Codes (GMP, GCP)
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Recognition of Training
New research methods/techniques how are the merits of new techniques
gauged? who will identify the right system? feedback is critical
Proof of expertise – what is acceptable? recognition of trainers does experience necessarily confer
expertise?
Maintenance of a training database where is the data stored when and how is it updated methods for AEC approval of changes
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Other Items
Ensuring Closure of all AEC Action items methods of monitoring and reporting
AEC Communication channels project investigator availability animal facilities/updates/feedback executive management of 2
companies roles of Chairperson and Secretary
Training of new investigators using the right (lay) language why and what the AEC needs to know applications in on time!
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The End