4 in 1 (◕‿-)

for this January, we are going to have new mOdule for this BesT programme, Technical mOdule

this 8 days for Technical mOdule was conducted by CReST EvendZ 

(Clinical Research Skills Training & Events)

we got a lot of theory about the given topic, it is very useful to us when we working one day...

10 jan 2011

session 1 : Intellectual Property Protection in Malaysia

by Assc Prof Rohazar Wati Zuallcobley

• intangible rise & Intellectual Property protection
• patent
• trade mark
• confidential information & trade secret

11 jan 2011

session 2 : Introduction to Clinical Research & Ethics

by Dr Sia Koon Ket

• what is Clinical Research?
• phases of Clinical Research / Trial
• Biomedical Ethics
• Research ethics
• Balancing principle 

12 jan 2011

session 3 : Sponsor's role

by Ms Adeline Kwok

• ICH-GCP
• Role of the sponsor - ICH-GCP
• Role of the investigator - ICH-GCP
• Adverse Event Surveillance

13 jan 2011

session 4 : 

Regulatory Practices in Msia & GXP

by 2 speaker : Dr Kamaruzaman Saleh & Dr Tajuddin Akasah

Dr Kamaruzaman Saleh

• Regulatory aspects of drug development in Msia
• Compliance Monitoring Authority
• Clinical trial import licence (CTIL)
• clinical trial exemption (CTX)
• quality assurance QA
• quality control QC
• audit in Good clinical practice (GCP)
• Good laboratory practice (GLP)

Dr Tajuddin Akasah

• Quality & Good Manufacturing Practice(GMP)

creative & innovation

Trainer = Dr Roland Xavier

what did you see and get from a particular product ??

is it ImpOrtant  Or Interesting ?? 

NABC Value Proposition

whats that ?? let me tell u

Identify the marketplace Need for your product or service

Define the “golden nugget”  or the unique advantage of your Approach

Outline the Benefits to the customer, partners in the market ecosystem

Pinpoint the Competition and systematically compare your approach to competitive products or services

InnO BiO & Stellagen

On 5^th January 2011, we Trainee of BesT programme UniRazak , have Students visit to Inno Biologics at Putra Nilai, Negeri Sembilan . Our jouney takes about 1 hour, by bus. The other group was visit Stellagen that located at Sri Batu Caves Industrial Park  .

       

        

        Inno Biologics was well established in 2002, and Inno Biologics is Malaysia’s first cGMP modular biopharmaceutical production plant. Inno Biologics specializes in mammalian cell culture technology and operates the state-of-the-art cGMP facility for the production of biopharmaceuticals. The facility is built to comply with European Medical Agency (EMEA) and United States Food and Drug Administration (FDA) regulatory requirements.  Inno Biologics has entered into a 10-year cooperation agreement with Boehringer Ingelheim to have non-exclusive access to Boehringer Ingelheim’s comprehensive manufacturing technology platform for biopharmaceutical production. Inno Biologics also have strategic collaboration with the commercial arm of Centre of Molecular Immunology (CIM), Cuba in Technology licensing for the Humanisation of Antibody. With the GE Healthcare, a conferment on seed site status to Inno Biologics. Inno Biologics will gain preferred access to GE latest innovation of related technology.

        They offer complete services from upstream to downstream operation for the development of customer’s therapeutic proteins. Their reliable, rapid and cost effective services will reduce risks, cost and time investment. This will ensure their customers will get the product candidates into the market in line with their vision and strategy. This is the list for complete range of services provided by Inno Biologics ; contract research, antibody development, humanization services, cell line development, protein expression, yield improvement, cell banking, process development, analytics, scale up from non cGMP to cGMP and cGMP manufacturing – 200L & 1000L.

        From this visit, all of we were brought by Inno Bio executive team to visit  around Inno Biologics. The coverage area of Inno Biologics quite large and wide.  Inno Biologics , they were provide the services to the clients  like I said in previous paragraph. There’s a large scale of laboratory ; Process Science Laboratory and Protein Science Laboratory. In Process Science Laboratory was involved with Purification Laboratory, Filtration Laboratory and Bioreactor and Recovery Laboratory.  There’s a big reactor that used for operation process. In Inno Biologics have the manufacturing sector that operates the state-of-the-art cGMP facility for the production of biopharmaceuticals. For Stellagen, is a Biotech Company with the primary objective to identify, develop and commercialise technologies related to animal health, consumer health, microbiology and biochemical industries. StellarLac(TM), which has undergone a 12 years research in UPM. This product is a feed supplement for poultry and it is meant to replace the antibiotics as growth promoter. It is known as probiotic since the product is consisted of 11 strains of friendly bacteria that can improve a chicken's intestinal bacteria balance and its digestion of chicken feed. It also helps to restore the presence of beneficial bacteria, which strengthen the intestinal system against disease-causing organisms. This makes Stellarlac the most suitable alternative for antibiotics as growth promoter since the usage of the latter will be banned internationally starting from 1 January 2006. This company is a growing company, there 2% market they have penetrated and mostly in Southern Malaysia. This company was small in place and also just have five team members, that located at Sri Batu Caves Industrial Park  

        My opinion about Inno Biologics in future about 10 years, is I hope Inno Biologics will fulfill the the mission and vison that they holds. Inno Biologics must to expand effort to ensure the sustainabilitygrowth. . Inno Biologics will be a world leading business organisation providing biopharmaceutical development and services for better quality of life. And Inno Biologics now already on the right track in order to be the leader in innovative biologics development and manufacturing.  By achieving that Inno Biologics will give full contribution to the nation’s economic growth. By the increasing development in the future, they will create critical mass of talent in biorelated industries.

        As conclusion, this visit was a great and so much useful for me and all of us. From this visit, it’s open my eyes clearly to the future career and what particular environment for my future jobs. And I hope one day I willl work with Inno Biologics. Thank you to S.E.E.D and Biotechcorp for giving us this great opportunity. 

be creative to get new ideas

hye guyss

our trainer for this session is Prof Barjoyai .... hehe his name very unique

i wish he's the only one Barjoyai in the wOrld ...  bravO prof

this session going on for 3 days

Prof was show his doraemon's bag ... full with the interesting item ... very amazing

the item that Prof show to very rarely founded in Malaysia ....

the most quote , what Prof always said to us:

New idea is wrong idea , wrong idea is gOOd idea

i always remember that

during our class, we have been introduced by Prof, The Microwave rice cooker.

Thus, it make it easy to everyone .. with the easy way to use it.

by the way, we get the oppurtunity to cook nasi briyani, for our lunch !!!

Next, on the same time , Prof has shown to us a Bread-maker

the combination of flour + water + salt + the additional ingredient 

were been mix and mold in that machine .... 

in order to form a dough, then it was baked in that machine also.

very easy 

the 3rd day, we have been giving a task to do a doodle

then , everyone's painting was paste on the wall

then, the choosen one was being pick , Prof will comment it

below, my group's doodle huhu

the finale

28th December 2010 is our final day in communication skills

what we do for that day ??  

today Mdm Liza & Mdm Sita was here with us. we were going to  present the business proposal by group which is 30 minutes for each group. hehe my group XX power , take 2nd for the turn. its quite early to present, but my group member Yatie got an interview. good luck to her. Today, all of us looks pretty, awesome, gorgeous and looks professional with our attire.... huhuhu. 

my group are going to present about Eco-PALF fiber. my part is Investment Highlight & The Conclusion . I'm the finishing one. fuhh everything goes well and smooth. I think my group do it very great. And I think , i become more confident and feel calm to talk. Alhamdullilah. 

about 9 group must be to present , and we finish late, about 6 pm. Its ok, because everything are settle...

*i'll upload my group presentation pic later =)

NLP

The role of Neuro-linguistic programming in commnication session by Mr Faizal Kamal, was the last session or class for our Communication Module, before all of us are going to the finale presentation day.

in this session i've learn about how to delete unwanted memory, this topic was demostrate by mr Faizal to our friend, Firdaus . then we do it in a pair.
then we learn about what kind of sensory part that we alert most.

we were divided in group into 3 and tested each member on touch,  sound and visual sensors. based from this, my friends said that i'm best in touch sense .. huhuhu actually it is average i think.

the activity is this session that i remember the most is when mr faizal ask 2 gurls, 1st girl was asked by mr faizal to think about the best/sad things that happen to her before this .... and then the 2nd gurl was asked to 'selami perasaan' the 1st gurl, just by sitting next her. for a few minutes, the 2nd gurl 'terasa sebak dan mengalirkan air mata' ..... so suprise and impress.

 access , amplify , anchor