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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5855_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Developing a Training and Continuous Training Program for ASEAN Inspectors
States were requested to review the training modules and curric­ulum proposed and to explore funding mechanisms. The ASEAN JSC on GMP Inspection was also advised to consider making use of ISPE regional conferences and seminars to publicize the ASEAN harmonization initiative on GMP inspection, as well as to seek out training opportunities via ISPE aliates in the Asia-Pacific region. These included the Singapore, Japan, Indonesia, Thailand and Phil­ippines ISPE Aliates.
Following this major collaborative TNA initiative, an invitation was extended to the Chair of ASEAN JSC on GMP Inspection to deliver a keynote presentation at the ISPE Singapore Conference
2012. Arising from this presentation, Pharmaceutical Engineer-
ing, the technical magazine of ISPE, published an article entitled “A SE A N Harmonization on GMP Inspection and Training of ASEAN Inspectors”, in its January/February 2013 issue. Essen­tially, this article provided a progress report on ASEAN harmoni­zation on GMP inspection and its proposed training initiatives to fulfil ASEAN Economic Community 2015. The publication of this article by ISPE Pharmaceutical Engineering was very good publicity for the harmonization eort by ASEAN as the magazine is widely read globally by pharmaceutical manufacturing professionals, consultants, academia and regulators. The following year, a sim­ilar presentation was also delivered at the ISPE Japan Conference in Tokyo on 11 April 2013. This event was also very well attended by more than 300 participants from the Japanese pharmaceutical industry, the Japan Pharmaceutical and Medical Device Agency, academia as well as editorial sta from Pharm Tech Japan — a leading Japanese pharmaceutical journal. Pharm Tech Japan published a paper entitled “Towards a Harmonized ASEAN GMP Inspection
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
System using the PIC/S Framework as Benchmark” in its June and July 2013 issues, in Japanese and English respectively. The co-authors of this article were Mr. Bob Tribe from ISPE Asia­Pacific, Prof. Chan Lai Wah from the National University of Singapore (NUS) and Mr. Sia Chong Hock from the Singapore HSA, who was concurrently the Chair of ASEAN JSC on GMP Inspection. The Japanese version of the article was translated by a bilingual Japanese sta from ISPE Japan Aliate.
ASEAN harmonization on GMP inspection and training of inspectors
Updates on ASEAN harmonization on pharmaceutical inspections and the progress on the implementation of the ASEAN Sectoral
Developing a Training and Continuous Training Program for ASEAN Inspectors
MRA were also shared with participants at several other ISPE Con­ferences over the years. These conferences included the:
· ISPE Indonesia Conference held at the Holiday Inn Kemayoran,
Jakarta from 9 to 10 May 2017;
· ISPE Philippines Conference held at the Shangri-La Makati,
Manila from 25 to June 2018;
· ISPE Thailand Conference held at the Ambassador Hotel from
16 to 17 July 2018;
· ISPE Singapore Conference held at Suntec Convention Centre
from 30 to 31 August 2018 and;
· ISPE Asia-Pacific Conference held at Marina Mandarin Hotel
from 30 September to 1 October 2019.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
ISPE Singapore 2018 Conference: Suntec Convention Centre, 30–31 August 2018 From left to right: Moderator (Robert Tribe) from ISPE with regulatory panelists from Thailand, Russia, Europe, Singapore and PIC/S — 30 August 2018
For all his unstinting eorts and dedicated contributions to Singa­pore, ASEAN and beyond, in the field of pharmaceutical inspection, regulation and quality assurance of medicinal products, the ISPE Singapore Aliate bestowed on the co-author (Sia Chong Hock) an award in recognition for his “Lifetime Contribution to Pharmaceu­tical Regulatory Practices”. This award was presented to him on the occasion of the 16th Anniversary Celebration of ISPE Singapore Al­iate on 25 August 2016.
Developing a Training and Continuous Training Program for ASEAN Inspectors
77
Co-author (Sia Chong Hock) recognized for “lifetime contribution to pharmaceu-
tical regulatory services” by ISPE Singapore Aliate on 25 August 2016

3.3. Collaboration with Korea Ministry of Food and Drug Safety (MFDS)

The ASEAN JSC on GMP Inspection has to go beyond having just five ASEAN Listed Inspection Services in its Register of ASEAN Listed Inspection Services. The ultimate goal is to eventually have 10 ASEAN Listed Inspection Services in order to optimize and reap all the benefits of the ASEAN Sectoral MRA on GMP Inspec­tion. This would necessitate standardizing and harmonizing the inspection framework for all ASEAN Member States, including the
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Visit to Myung In Pharmaceutical, Korea — 18 October 2016
competency and skills of the ASEAN GMP inspectors. The training and continual training of ASEAN inspectors is crucial in helping the inspectors keep abreast with the latest developments in GMP compliance and quality assurance of medicinal products. ASEAN is fortunate to find suitable collaborators and partners in this mis­sion. At an inaugural Korea-ASEAN GMP Conference held from 19 to 20 April 2015 in Seoul, the MFDS expressed strong interest in advancing technical cooperation with ASEAN on GMP training. A Concept Note on training of ASEAN Inspectors was submitted by ASEAN JSC to Korea MFDS in November 2015. This led to the invitation of Korea MFDS to the ASEAN JSC Meeting held in Siem Reap, Cambodia from 17 to 18 May 2016. The Siem Reap meeting resulted in a successful and breakthrough outcome, with both par­ties agreeing on a training framework guided by an ASEAN-ISPE TNA (for inspectors) that was conducted in 2010. For practical reasons and ease of implementation, Korea MFDS recommended
Developing a Training and Continuous Training Program for ASEAN Inspectors
that the training courses be conducted in South Korea. This arrange­ment was intended to facilitate seamlessly the conduct of classroom lectures in South Korea, supplemented with experiential training in the form of on-site visits to pharmaceutical manufacturers, also located in South Korea. The language of training and instruction would be in English. The ASEAN JSC on GMP Inspection agreed in principle with the proposals from Korea MFDS. Following the May 2016 Siem Reap meeting, one event after another happened very quickly. An ASEAN delegation of pharmaceutical GMP inspectors, including Chair of ASEAN JSC on GMP Inspection, was invited to participate in the 2016 Korea-ASEAN Pharmaceutical GMP Con­ference, held in Seoul from 18 to 20 October 2016. The agenda for this conference included country presentations from South Korea and ASEAN delegates and site visits to Myung In Pharmaceuticals and other South Korean pharmaceutical manufacturing facilities, as well as a taste of South Korean cuisines and an immersion into South Korean culture — all very educational, interactive and highly enriching for everyone. There was also high-profile media coverage,
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“Money Today Network”, 18 October 2016
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
including prime-time television coverage of this 2016 Korea-ASEAN Pharmaceutical GMP Conference by a South Korean broadcasting company, namely, Money Today Network (see image on previous page).
To capture this landmark 2016 Korea-ASEAN GMP Conference, a group photo of the ASEAN delegates, together with our South Korean counterparts, was taken against the beautiful skyline of Seoul.
Korea-ASEAN GMP conference 2016
Seoul, 18–20 October 2016
By September 2017, the first Korea-ASEAN Inspectors’ Train­ing Course was conducted in the city of Osong, South Korea from 4 to 7 September by Korea MFDS in collaboration with the Korea Pharmaceutical Manufacturers Association, now renamed as the
Developing a Training and Continuous Training Program for ASEAN Inspectors
Korea Pharmaceutical and Biopharmaceutical Manufacturers Asso­ciation. This inaugural training course included both classroom lectures as well as site visits to selected South Korean pharmaceuti­cal manufacturing facilities. The second and third training courses for ASEAN inspectors were conducted in 2018 and 2019 respectively. Again, there were didactic classroom lectures together with experi­ential site visits to pharmaceutical manufacturing facilities such as LG Chemicals and CJ Healthcare, a company with the catchy slogan “Heal the World”, which sounded like a Michael Jackson hit song. There were also visits to biopharmaceutical manufacturing facil­ities such as Samsung Biologics and Celltrion. These South Korean pharmaceutical and biopharmaceutical manufacturers had state-of­the-art facilities and manufacturing standards, comparable to other world-class MNC pharmaceutical manufacturers.
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Site visit to Korean manufacturers
1st Korea-ASEAN Inspectors’ Training Course
Osong, Korea, 4-7 September 2017
Classroom lecture