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Fostering a Conducive Landscape for Biotechnology Evolution

Dalam dokumen Local People, Global Performance (Halaman 44-60)

November 1 - 3 BioMalaysia 2010 Conference & Exhibition Kuala Lumpur Convention Centre, Malaysia

This was the premier biotechnology event of the year for BiotechCorp to showcase latest research findings, state-of-the-art technology and new product launches. It also served as a platform for experts to engage in an exchange of knowledge, experiences and opinions in the development of the biotechnology industries. The event attracted over 7,400 participants from 17 countries.

November 13 - 14 BioCareer 2010 Kuala Lumpur Convention Centre, Malaysia

Themed “Emerging Innovative Careers in Biotechnology”, the event was targeted at supporting Government initiatives to reduce unemployment and increase innovative careers in the

biotechnology industry. The 2-day career fair attracted almost 4500 visitors and a total of 40 exhibitors from various companies.

Fostering a Conducive Landscape for

November 1 - 3 BioMalaysia 2010 Conference & Exhibition Kuala Lumpur Convention Centre, Malaysia

This was the premier biotechnology event of the year for BiotechCorp to showcase latest research findings, state-of-the-art technology and new product launches. It also served as a platform for experts to engage in an exchange of knowledge, experiences and opinions in the development of the biotechnology industries. The event attracted over 7,400 participants from 17 countries.

November 13 - 14 BioCareer 2010 Kuala Lumpur Convention Centre, Malaysia

Themed “Emerging Innovative Careers in Biotechnology”, the event was targeted at supporting Government initiatives to reduce unemployment and increase innovative careers in the

biotechnology industry. The 2-day career fair attracted almost 4500 visitors and a total of 40 exhibitors from various companies.

Fostering a Conducive Landscape for Biotechnology Evolution

Legal & Regulatory

As the Malaysian biotechnology industry continues to be developed, the importance of having a robust and relevant legal and regulatory framework is imperative.

As the Malaysian Biotechnology Corporation Sdn Bhd (BiotechCorp) champions industry growth via the National Biotechnology Policy (NBP), the legal and regulatory function exists to ensure checks and balances are in place and the creation of an optimum regulatory environment that encourages further growth for the industry consistent with Thrust 7 of the NBP which emphasises the importance of establishing a solid and supportive regulatory framework for the development of biotechnology.

Focus Areas:

1. The establishment of a supportive regulatory framework and environment that takes into consideration the developmental aspirations of the nation and encourages innovation whilst ensuring public safety.

2. Contributing towards the balanced creation of safeguards to regulate access to local genetic resources, seeking not to hamper genuine initiatives and cooperation between the access provider and access seeker.

3. Contributing towards the development of a strong regulatory framework for intellectual property rights (IPR).

4. Encouraging the creation and filing of biotech-related patents with a view to commercialise.

5. The promotion and support initiatives for the attainment of international accreditation and compliance with international standards.

6. Contributing towards the establishment of a strong and enabling regulatory framework for the enhancement of efficacy in relation to product registration.

Key Results:

BioSafety Framework

Issue / Activity Result

Regulations under the Biosafety Framework provides certainty to the biotechnology industry that a specific process to handle the release, importation, exportation and contained use of living modified organisms (LMOs) has been put in place. BiotechCorp played a role in the promulgation of the law and actively

participated in the consultation exercise.

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BioSafety Framework

Issue / Activity Result

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Category No of Participants

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BioSafety Framework

Issue / Activity Result

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Category No of Participants

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Issue / Activity Result International

Accreditation - Good Laboratory Practices (GLP)

International

Accreditation - Good Clinical Practices (GCP)

The GLP Compliance Programme to certify adherence of test facilities to the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and Compliance Monitoring have been initiated by the Malaysian Compliance Monitoring Authorities (see note below). BiotechCorp is currently working with these agencies in the certification of test facilities through the provision of funding for numerous capacity building initiatives. These includes the identification of potential test facilities for GLP compliance.

t *O(-1JOTQFDUJPOXFSFDPOEVDUFEPOOJOFDPNNJUUFEUFTU facilities in which three are found to be ready for testing in compliance to the OECD GLP requirements.

Note:

Malaysia was made a provisional adherent to the Organisation for Economic Co-operation and Development (OECD) Mutual

"DDFQUBODFPG%BUB ."%TZTUFNJO5IFZFBSTBX UIFDPOUJOVFEJNQMFNFOUBUJPOPGUIF0&$%(-1GSBNFXPSLXIJDI is applicable to non-clinical health and environment safety studies.

The Government had designated the National Pharmaceutical Control Bureau (NPCB) and Department of Standards Malaysia (Standards Malaysia) as the Malaysian Compliance Monitoring Authorities (CMAs). Malaysia intends to achieve full adherent TUBUVTUPUIF0&$%."%TZTUFNCZ

The Ministry of Health continues to ensure that each clinical trial proposal goes through a rigorous review and the trial itself is strictly monitored and regularly audited. The Clinical Research and Compliance Section of NPCB plays an important role in issuing the Clinical Trial Import License (CTIL) and ensuring compliance with GCP. The obvious benefit of GCP is acknowledged by NPCB as Malaysia becomes a more active participant in international drug research.

t *OTFWFO($1*OWFTUJHBUPSUSBJOJOHQSPHSBNNFTXFSF held in collaboration with the Clinical Research Centre (CRC) and the Associates of Clinical Research Professionals Malaysia "$31.XIFSFCZPWFS($1JOWFTUJHBUPSTXFSFUSBJOFE

Issue / Activity Result International

Accreditation – Good Clinical Practices (GCP)

t 'PVSPUIFSXPSLTIPQTDPOEVDUFEJOJODMVEFUIFA8PSLTIPQ for Study Directors and Quality Assurance Personnel of GLP 4UVEJFTA+PJOU$3$#JPUFDI$PSQ$MJOJDBM3FTFBSDI (PWFSOBODF&UIJDT8PSLTIPQBA4ZNQPTJVNPO

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Training Regulators In addition to creating awareness among industry players and the HFOFSBMQVCMJD#JPUFDI$PSQBTTJTUFEJOUIFUSBJOJOHPGLFZ regulators to create awareness and enhance their own skills in various important areas.

t Collaboration with the Intellectual Property Corporation of Malaysia .Z*10UPQSPWJEF*1-BXUSBJOJOHGPSUIFKVEJDJBSZPGGJDFSTPGUIF Attorney General’s Chambers and enforcement officers from the .JOJTUSZPG%PNFTUJD5SBEF$PPQFSBUJWFTBOE$POTVNFSJTNUP support the establishment of the IP Courts in Malaysia.

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t $PMMBCPSBUJPOXJUIUIF/BUJPOBM1IBSNBDFVUJDBM$POUSPM#VSFBV (NPCB) of the Ministry of Health and the Department of

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#JPTJNJMBST.BOVGBDUVSJOHJO,VBMB-VNQVSUPFOIBODF awareness and skills in the quality aspects of biosimilars and herbal medicine.

Issue / Activity Result International

Accreditation - Good Laboratory Practices (GLP)

International

Accreditation - Good Clinical Practices (GCP)

The GLP Compliance Programme to certify adherence of test facilities to the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and Compliance Monitoring have been initiated by the Malaysian Compliance Monitoring Authorities (see note below). BiotechCorp is currently working with these agencies in the certification of test facilities through the provision of funding for numerous capacity building initiatives. These includes the identification of potential test facilities for GLP compliance.

t *O(-1JOTQFDUJPOXFSFDPOEVDUFEPOOJOFDPNNJUUFEUFTU facilities in which three are found to be ready for testing in compliance to the OECD GLP requirements.

Note:

Malaysia was made a provisional adherent to the Organisation for Economic Co-operation and Development (OECD) Mutual

"DDFQUBODFPG%BUB ."%TZTUFNJO5IFZFBSTBX UIFDPOUJOVFEJNQMFNFOUBUJPOPGUIF0&$%(-1GSBNFXPSLXIJDI is applicable to non-clinical health and environment safety studies.

The Government had designated the National Pharmaceutical Control Bureau (NPCB) and Department of Standards Malaysia (Standards Malaysia) as the Malaysian Compliance Monitoring Authorities (CMAs). Malaysia intends to achieve full adherent TUBUVTUPUIF0&$%."%TZTUFNCZ

The Ministry of Health continues to ensure that each clinical trial proposal goes through a rigorous review and the trial itself is strictly monitored and regularly audited. The Clinical Research and Compliance Section of NPCB plays an important role in issuing the Clinical Trial Import License (CTIL) and ensuring compliance with GCP. The obvious benefit of GCP is acknowledged by NPCB as Malaysia becomes a more active participant in international drug research.

t *OTFWFO($1*OWFTUJHBUPSUSBJOJOHQSPHSBNNFTXFSF held in collaboration with the Clinical Research Centre (CRC) and the Associates of Clinical Research Professionals Malaysia "$31.XIFSFCZPWFS($1JOWFTUJHBUPSTXFSFUSBJOFE

Issue / Activity Result International

Accreditation – Good Clinical Practices (GCP)

t 'PVSPUIFSXPSLTIPQTDPOEVDUFEJOJODMVEFUIFA8PSLTIPQ for Study Directors and Quality Assurance Personnel of GLP 4UVEJFTA+PJOU$3$#JPUFDI$PSQ$MJOJDBM3FTFBSDI (PWFSOBODF&UIJDT8PSLTIPQBA4ZNQPTJVNPO

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Training Regulators In addition to creating awareness among industry players and the HFOFSBMQVCMJD#JPUFDI$PSQBTTJTUFEJOUIFUSBJOJOHPGLFZ regulators to create awareness and enhance their own skills in various important areas.

t Collaboration with the Intellectual Property Corporation of Malaysia .Z*10UPQSPWJEF*1-BXUSBJOJOHGPSUIFKVEJDJBSZPGGJDFSTPGUIF Attorney General’s Chambers and enforcement officers from the .JOJTUSZPG%PNFTUJD5SBEF$PPQFSBUJWFTBOE$POTVNFSJTNUP support the establishment of the IP Courts in Malaysia.

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t $PMMBCPSBUJPOXJUIUIF/BUJPOBM1IBSNBDFVUJDBM$POUSPM#VSFBV (NPCB) of the Ministry of Health and the Department of

Standards Malaysia (STANDARDS MALAYSIA) of the Ministry of 4DJFODF5FDIOPMPHZBOE*OOPWBUJPO .045*UPQSPWJEFUIF Organisation for Economic Cooperation and Development’s (OECD) Principles of Good Laboratory Practices (GLP) training for their respective GLP inspectors worldwide so as to ensure quality inspections and smooth completion of the OECD GLP framework for Malaysia.

t $PMMBCPSBUJPOXJUI/1$#UPQSPWJEFUSBJOJOHUPBLFZSFHVMBUPS at the International Regulatory Conference on Herbal Medicine .FFUJOHBOE8PSLTIPQBOEPO2$3FRVJSFNFOUTGPS

#JPTJNJMBST.BOVGBDUVSJOHJO,VBMB-VNQVSUPFOIBODF awareness and skills in the quality aspects of biosimilars and herbal medicine.

Next Steps for Legal and Regulatory:

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Financial Infrastructure

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Focus Areas:

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*OWFTUNFOUTJO Issue / Activity Key Results:

Result

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Next Steps for Legal and Regulatory:

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Financial Infrastructure

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Focus Areas:

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*OWFTUNFOUTJO Issue / Activity Key Results:

Result

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Establishment of funds to assist the industry

Issue / Activity Key Results:

Result

BiotechCorp provides assistance towards efforts to establish dedicated biotechnology funds.

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Raising awareness on funding

opportunities and encouraging investment

BiotechCorp continued to create awareness and interest among the financial and investment community on the business and UFDIOJDBMBTQFDUTPGUIFCJPUFDIOPMPHZTFDUPSMPDBMMZBOEHMPCBMMZ with the intention for them to eventually consider investment within the industry.

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BioEducation 4ZNQPTJVN Issue / Activity Key Results:

Result

5IF4ZNQPTJVNXBTIFMEUPEFWFMPQBXBSFOFTTBNPOHTUTDJFODF teachers and career counsellors about biotechnology fields and available career opportunities so they would be able to provide this information to students.

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Biotechnology Entrepreneurship 4QFDJBM5SBJOJOH #F451SPHSBNNF BOE(SBEVBUJPO

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Next Steps for Financial Infrastructure Development:

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Human Capital Development

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Focus Areas:

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Establishment of funds to assist the industry

Issue / Activity Key Results:

Result

BiotechCorp provides assistance towards efforts to establish dedicated biotechnology funds.

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Raising awareness on funding

opportunities and encouraging investment

BiotechCorp continued to create awareness and interest among the financial and investment community on the business and UFDIOJDBMBTQFDUTPGUIFCJPUFDIOPMPHZTFDUPSMPDBMMZBOEHMPCBMMZ with the intention for them to eventually consider investment within the industry.

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BioEducation 4ZNQPTJVN Issue / Activity Key Results:

Result

5IF4ZNQPTJVNXBTIFMEUPEFWFMPQBXBSFOFTTBNPOHTUTDJFODF teachers and career counsellors about biotechnology fields and available career opportunities so they would be able to provide this information to students.

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Biotechnology Entrepreneurship 4QFDJBM5SBJOJOH #F451SPHSBNNF BOE(SBEVBUJPO

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Human Capital Development

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Focus Areas:

%FWFMPQTLJMMFELOPXMFEHFBCMFBOEDPNQFUFOUIVNBODBQJUBMUPFOTVSFBEFRVBUFTVQQMZPG human capital for the biotechnology ecosystem.

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Dalam dokumen Local People, Global Performance (Halaman 44-60)