01 Jul 2019 - 01 Apr 2019 Past Event

Seminar on Understanding of CGTP Requirements and Guidelines

Venue: Eastin Hotel, Petaling Jaya, Selangor
Theme: Time: 2.00-5.00pm

Speaker:
Puan Arpah Abas
Head of Biotechnology Section, Centre for Product Registration, NPCB

A key objective of this Seminar is for the industry to gain a better understanding on the new regulatory requirements  for Cell & Gene Therapy Products (CGTP). The NPCB has recently disseminated a draft guideline on CGTP for stakeholders’ comments. As this is a new area to most members of our industry, a Subject Matter Expert from NPCB has been invited to give a presentation on the CGTP requirements and the proposed guideline. A presentation on Regulatory updates on Biotherapeutics including Biosimilars will also be covered at this Seminar.  It is envisaged that this seminar will help to enlighten the industry on these subjects and will enable the industry to keep abreast of advances in biologicals and to work in tandem with MoH's evolving regulatory requirements in these new areas.

>>> Download Registration Form - PDF, 188 KB

 

For enquiries on fee payment, kindly contact seminar secretariat office:

Pharmaceutical Association of Malaysia (PhAMA), 
C-18-2, Block C,Dataran 32 (3 Two Square), 
46300 Petaling Jaya, Selangor. 
Tel: 03-79608322/23
Fax: 03-79608324
Email: janice@phama.org.my