Request for expressions of interest for selec1on of members for the Bioavailability/Bioequivalence Technical Working Group under the Evalua1on of Medicinal Products Technical CommiDee. [...] These con9nental technical commiAees are working to support the AU in the opera9onaliza9on of the African Medicines Agency (AMA) and among other, the TCs shall be responsible for conduc9ng scien9fic assessments and to providing scien9fic opinions on the safety, efficacy, and quality of priority medical products. [...] A priority area for AMRH is harmoniza9on of requirements for the registra9on of generic1 products, which rely heavily on the use of bioequivalence (BE) studies, a subset of bioavailability (BA) studies, to support the products safety and efficacy. [...] In this respect, the AMRH Secretariat invites Expression of Interests (EoIs) from experts in BA/BE assessments, inspec9ons and research to be members of the con9nental TWG for harmoniza9on of BA/BE requirements. [...] Interested applicants with the required competencies should submit the following: A cover leAer expressing interest, addressed to the AMRH EMP TC Secretariat, sta9ng their areas of exper9se and progressive experience specifically in the area of bioavailability or bioequivalence studies including the types of products, the types of studies (i.e.
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- The desired qualifica9on and experience for assessors are as follows 1
- A minimum of 5 years of experience in maAers related to BABE studies including assessment research GCP inspec9ons etc. 1
- Experience assessing BABE studies or associated compara9ve studies for complex products i.e. topical products drug-device combina9ons suppositories etc. will be an added advantage 2
- Experience as an assessor for the WHO Prequalifica9on program for medicines or involvement with development of guidelines with the ICH or WHO will be an added advantage. 2
- Interested applicants with the required competencies should submit the following 2
- A detailed CV indica9ng relevant experiences as described above. The CV should not be more than 5 pages long and should be reflec9ve of area applied for. 2
- Interested and poten9al candidates who wish to be provided with clarifica9ons on this maAer may contact the AMRH Secretariat amrhnepad.org. 2
- The deadline for submission is 30 April 2024 at 1400 South-African Pme . Late submission of Expression of Interest shall not be accepted for evalua9on irrespec9ve of circumstances. 2
