Centre for Organisational Development
Noting the importance of both internal and external communications, NPCB continues to work closely and collaborate with local industry, industry associations, health professionals, academia, consumers as well as other stakeholders. This is mainly with the aim to further enhance the overall effectiveness of the regulatory system in Malaysia.
- Responsible in providing product/drug information to officers involved in product evaluation and also to those who are involved in patient care to provide the best service to the public.
- Ensure only updated information is found on the NPCB website.
- Monitor NPCB’S computer system and to ensure that the online registration system (QUEST 3) functions smoothly.
- Responsible in providing information on product registration procedures and other relevent matters such as registration status (for pharmaceutical, traditional, and cosmetic products) and other information which is required by the public.
- Organise education programes for professionals and public through exhibition activity.
- Coordinate training for the officers.
- Coordinate documentation and activity related to ISO.
- Management of the Information Technology (IT) System
- Maintenance of NPCB website
- Handling of enquiries
- Publications of magazine related to DCA policies (Berita Ubat-ubatan) and the NPCB Annual Report
- Co-ordinating dialogues with the relevant industry associations
- Trainings and Courses
- Handling local and international visitors
- Management of the Information Technology (IT) System
The ICT Section had put in relentless efforts to ensure the smooth running of the QUEST 3 System. This included the establishment of a dedicated IT Unit within NPCB which oversees the computer system as well as a Helpdesk within NPCB (to ensure better monitoring of problems encountered by customers), outsourcing of maintenance and troubleshooting.
- Maintenance of the NPCB Website
Several new/updated articles such as guidelines to facilitate regulatory matters were revised and developed. The adopted documents are downloadable from the official NPCB website
- Handling of Enqueries
Centre for Organisational Development plays an important role in supplying general information to consumers and industries. A total of 3,062 enquiries had been received by the centre in 2010. An increase of 15% (Figure 43) was seen compared to 2009 which could be attributed to the introduction of QUEST 3 system in product registration
In 2010, 4 editions of the Drug Control Authority (DCA) bulletin i.e Berita Ubat-ubatan (containing news and updated policies of the DCA) and 1 edition of NPCB Annual Report were published.
- Coordinating Dialogues with the Relevant Industry Associations
The NPCB works closely and collaborates with the local industry, industry associations, health professionals, academia, consumers and other stakeholders to further enhance the effectiveness of the comprehensive regulatory system currently in place. In line with this, NPCB frequently plans and organises meetings, technical working groups (TWG) and dialogues with the relevant industries when necessary. A total of 8 dialogue sessions were held in the year 2010 including dialogues with Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI), Cosmetic, Toiletry and Fragrance Association Malaysia (CFTA), Malaysia Direct Distribution Association (MDDA), Malaysian Homeopathic Medical Council, Malaysia Dietary Supplement Association (MADSA), Penguatkuasa Farmasi (BPF) and Malaysian Development Institute (MDI).
- Training and Courses
The Continuous Professional Development (CPD) Programme for pharmacist and assistant pharmacists is part of the training programme under the purview of this centre. In 2010, NPCB
organised a total of 103 CPD sessions which encompassed educational talks, workshops, Journal Club Sessions as well as seminars. Many NPCB staffs were also sent for relevant
training sessions organised by other parties/ organisations/ agencies.
- Visits by Local and International Visitors
As the only WHO Collaborating Centre for Regulatory Control of Pharmaceuticals in Malaysia, the NPCB continues to provide training in pharmaceutical quality assurance and regulatory affairs. In 2010, the NPCB had received 136 local visitors and 23 international visitors from countries such as Singapore, Maldives, India, Taiwan, Hong Kong, Ireland, Botswana, Tanzania and Nigeria.
The courses provided were designed specifically to fulfil the needs of the individual fellows. For example, training in pharmaceutical analysis, product registration, pharmacovigilance, surveillance, good manufacturing practice and licensing system.
The implementation of QUEST 3 system to replace QUEST 2 system signified an improvement in administration procedure. As a result, few challenges have evolved with the implementation of QUEST3. For instance, the public has to adapt to a new system and has to be trained and educated on how to use the functions in QUEST3. Besides, the new system of QUEST 3 has yet to mature as the function is not fully operational due to the migration of data that takes time to be done. In addition, the system has yet to stabilize technically.
The centre is facing another challenge of updating the official NPCB website. It requires continuous efforts to update the website regularly such as the latest status of QUEST 3, news and important announcements. Moreover, the centre has to ensure that the website is fully functional in areas such as links as well as search engines.
Last but not least, most of the staff at the centre are relatively junior. Thus, the lack of exposure and working experience would prove to be a challenge to the centre in overcoming its tasks.
THE WAY FORWARD
The centre will strive to stabilize QUEST 3 system in 2011. For instance, efforts will be made with the vendor of QUEST 3 in releasing downloadable patches that will stabilize and avoid interuption of usage of QUEST 3. As a whole, these will increase efficiency of the system.
In order to ensure that the staff at the centre are better equipped and gain more exposure, more structured trainings
and workshops should be provided to them. Furthermore, the addition of more senior staff is very much welcomed for their experience are vital to the centre.