CRO Staff Working in Emerging Markets Could Benefit From New Qualification
The Regulatory Affairs Professional Society (RAPS) has claimed that regulatory professionals working for contract research organisations (CROs) in emerging markets could ensure they are perceived as well as in developed countries by gaining a new certification.
A recent study by the Scope of Practice and Compensation Society reported that those members of regulatory staff working in the US or Europe have more experience than their colleagues working in emerging markets. The society's findings are based on an average of practical experience derived from a survey of 3000 professional who work across 58 countries.
Sherry Keramides, Executive Director of RAPS believes this is down to the €younger€ nature of the role in BRIC countries. She believes that the new qualification, the Regulatory Affairs Certification or RAC, could help regulatory professionals secure the trust of sponsors and increase the skill set they will employ on a day-by-day basis:
€I think it can help to alleviate problems in developing markets for instance with CROs. It definitely highlights whether the professional has the core competencies and skills.€
The provision of this post-academic credential compliments the joint efforts of RAPS and several regulators including the US Food and Drug Administration (FDA) and the World Health Organisation (WHO). The aim of their co-operation is to try and bolster infrastructure and staff pools in emerging markets.
There is even scope to have a pre-examination for the RAC in countries that are having notable problems with compliance:
€It may be done in steps, so they would have a pre RAC qualification before they take the actual Regulatory Affairs Certification exam.€
This is good news for reputable contract research organisations (CROs) that want to maintain their staff pool in BRIC countries. There has been a large upward trend in outsourcing to emerging markets as sponsors seek to take advantage of the of cost-savings measures that CROs with links to BRIC states can facilitate.
There is enormous value in emerging markets due to the number of potential trial participants. Furthermore, involvement in clinical trials can be the only way some patients in developing countries can have access to a satisfactory level of healthcare. When a sponsor is looking at contract research organisations, they should ensure they select a firm that has the know-how to tap into emerging market populations where there is a greater chance for patient enrolment being completed on time to avoid a costly delay in trial completion.
A recent study by the Scope of Practice and Compensation Society reported that those members of regulatory staff working in the US or Europe have more experience than their colleagues working in emerging markets. The society's findings are based on an average of practical experience derived from a survey of 3000 professional who work across 58 countries.
Sherry Keramides, Executive Director of RAPS believes this is down to the €younger€ nature of the role in BRIC countries. She believes that the new qualification, the Regulatory Affairs Certification or RAC, could help regulatory professionals secure the trust of sponsors and increase the skill set they will employ on a day-by-day basis:
€I think it can help to alleviate problems in developing markets for instance with CROs. It definitely highlights whether the professional has the core competencies and skills.€
The provision of this post-academic credential compliments the joint efforts of RAPS and several regulators including the US Food and Drug Administration (FDA) and the World Health Organisation (WHO). The aim of their co-operation is to try and bolster infrastructure and staff pools in emerging markets.
There is even scope to have a pre-examination for the RAC in countries that are having notable problems with compliance:
€It may be done in steps, so they would have a pre RAC qualification before they take the actual Regulatory Affairs Certification exam.€
This is good news for reputable contract research organisations (CROs) that want to maintain their staff pool in BRIC countries. There has been a large upward trend in outsourcing to emerging markets as sponsors seek to take advantage of the of cost-savings measures that CROs with links to BRIC states can facilitate.
There is enormous value in emerging markets due to the number of potential trial participants. Furthermore, involvement in clinical trials can be the only way some patients in developing countries can have access to a satisfactory level of healthcare. When a sponsor is looking at contract research organisations, they should ensure they select a firm that has the know-how to tap into emerging market populations where there is a greater chance for patient enrolment being completed on time to avoid a costly delay in trial completion.