NOMINATION CRITERIA FOR THE PANEL OF EXPERT (POE) FIRST-IN-HUMAN (FIH)

 

1.      The fields of expertise for the First-In-Human (FIH) Panel of Expert (POE) involved are according to the needs of the relevant FIH clinical studies:

●          Pharmacology

●          Toxicology

●          Pharmacokinetics

●          Medical Statistics

●          Pharmacognosy, if applicable

●          Medical Experts

 

2.      The criteria or nominating the Panel of Experts (POE) or First-In-Human (FIH) for Medical Experts are as follows:

 

2.1      Consultant Specialists/ Senior Consultant Specialists from MOH, nominations may consist of DCA expert panel members as nominated by the Medical Development Division (BPP) or other relevant divisions/institutes

 

a)      At least 1-2 specialists for each area/sub-area of expertise;

 

b)      Must have at least 2 years of service with MOH remaining;

 

c)      Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC)

 

d)      Not among the members/alternate members of DCA

 

2.2    Consultant Specialists/ Senior Consultant Specialists from universities with teaching hospitals, and nominations will be requested from Hospital Universiti Sains Malaysia (HUSM), Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM), Pusat Perubatan Universiti Malaya (PPUM)

 

a)      At least 1-2 specialists for each area/sub-area of expertise;

 

b)      Must have at least 2 years of service with the Ministry of Higher Education remaining;

 

c)      Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);

 

d)      Not among the members/alternate members of DCA

 

2.3      Consultant Specialists/ Senior Consultant Specialists from the private sector

 

a)      At least 1-2 specialists for each area/sub-area of expertise;

 

b)      Must possess relevant professional qualification and experience;

 

c)      Must have retired from the Public Service;

 

d)      Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);

 

e)      Not among the members/alternate members of DCA

 

3.      The criteria or nominating the Panel of Experts (POE) for First-In-Human (FIH) for the fields of Pharmacology, Toxicology, Pharmacokinetics, Medical Statistics and Pharmacognosy are as follows:

 

3.1      Lecturers/ Senior Lecturers from Public Universities

 

a)      At least 1-2 specialists for each field of expertise;

 

b)      Must have at least 2 years of service with the Ministry of Higher Education remaining;

 

c)      Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);

 

d)      Not among the members/alternate members of DCA

 

4.      All specialists in the POE FIH panel are appointed by the Deputy Director General of Pharmacy Services (TKPK(PF)) for a term of 3 years.

 

5.      The criteria or the existing POE FIH panel nominations are based on the decisions of the following meetings:

 

●      Product Evaluation Committee Meeting No. 14/2020, 14th December 2020

 

If there are any prospective panel members interested in becoming a panel member, they may contact Puan Suhailah Abu Bakar (e-mel: Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.; No. Tel: 03-7883 5580) or Puan Aiza Adlina Abdullah (e-mel:Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.; No. Tel: 03-7883 5466)