Hi everyone,
maybe you can help me with this question. As the regulation says
If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
we are now discussing how this "jointly" should be interpreted.
We are currently planning to allocate the PRRC responsibilities to 4 persons e.g. RA manager has the responsibility for point 3a (technical documentation), Qualified Person is responsible for point 3e (statement for clinical studies) aso. The allocation of this responsibilities are also covered in their job description.
But our question is now - although the separate responsibilites are defined in the job description is e.g. the RA manager nevertheless responsible for all points (3a to 3e), because it is a joint responsibility?
And how can the substitutes of the PRRC be implemented? Is it necessary to define the substitution for every PRRC? Do the 4 PRRCs have to substitute each other e.g. RA manager needs to substitute Qualified Person in regard of point 3e? Or would it be acceptable, that another, qualified RA manager can substitute the PRRC responsible for point 3a.
Sorry for so many questions and thank you in advance.
easycaz
maybe you can help me with this question. As the regulation says
If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
we are now discussing how this "jointly" should be interpreted.
We are currently planning to allocate the PRRC responsibilities to 4 persons e.g. RA manager has the responsibility for point 3a (technical documentation), Qualified Person is responsible for point 3e (statement for clinical studies) aso. The allocation of this responsibilities are also covered in their job description.
But our question is now - although the separate responsibilites are defined in the job description is e.g. the RA manager nevertheless responsible for all points (3a to 3e), because it is a joint responsibility?
And how can the substitutes of the PRRC be implemented? Is it necessary to define the substitution for every PRRC? Do the 4 PRRCs have to substitute each other e.g. RA manager needs to substitute Qualified Person in regard of point 3e? Or would it be acceptable, that another, qualified RA manager can substitute the PRRC responsible for point 3a.
Sorry for so many questions and thank you in advance.
easycaz