Contributing to human resource development on biologics in Asia-Pacific

Comments from Attendees

• Absolute recommended as it was a beneficial training.
• I will recommend the next CoE Workshop to my colleagues due to its exceptional value in the field of biotherapeutics. The workshop offers a unique blend of theoretical knowledge and practical hands-on experience, covering crucial aspects of biotherapeutics development, manufacturing, and regulation. Moreover, the networking opportunities with professionals from across the APEC region are invaluable for fostering potential collaborations and knowledge exchange. Participation in this workshop would significantly enhance our team's expertise and contribute to our organization's growth in the rapidly evolving biotherapeutics landscape.
• The information and knowledge gained was helpful to supplement our routine work.
• It is a valuable experience and opportunity to learn the latest knowledge on the manufacturing process and guidelines of biological products. I will definitely recommend this workshop to my colleagues.
• The lecture and Hands-on practices are very helpful for CMC reviewers to see the actual manufacturing process of biotherapeutics, not just from the flowcharts and description from submission dossiers.
• The training was very valuable, improved my practical skills and allowed me to learn new techniques and procedures.

Comments from Attendees

• The workshop's organization was excellent. I appreciated very much the time I spent at Kobe during the workshop.
• The courses and hands-on training are very useful for biotherapeutic CMC reviewers. The speaker also shared their fruitful experiences for reviewing and considerations which are meaningful for other reviewers' practice. The hands-on training gave participants chances to run the method which usually be applied to test the biotherapeutics and learn the principles as well.
• The arrangement for this workshop has already been perfect. Thank you so much for all your contributions.
• The program content is half a day of class and half a day of hands-on training keeps the attention focused and the topics are all related. I really liked the hands-on training part of the workshop was an outstanding experience. It provided was an opportunity to see "in practice" techniques and aspects of our activities as CMC reviewers that we can only see in the documentation.
• This course fulfills my expectations, expands my knowledge, and provides practical insights into CMC development and GMP inspection, which will benefit my current work and contribute to its continuous improvement.
• I really appreciate the combination of lecture and hands-on training for this workshop. It helped me further understand the manufacturing process of biotherapeutic products.
• Workshop in Kobe University was a great experience, because it is very important to update knowledge in CMC and have the opportunity to practice in the laboratory
• The hands-on training is very useful in helping evaluators and GMP inspectors to get a better understanding of the whole process of biotherapeutic products. Such knowledge we will never get it from dossiers/ guidelines/ books.
• This workshop is a very good opportunity to learn and understand other regulators' perspectives in CMC reviewing and GMP inspection as well. It is worth to have hands-on training, especially for those reviewers who are not familiar with the analytical test.
• This workshop is a very great learning opportunity for CMC reviewers to further understand the manufacturing process of biotherapeutic products. We have interacted and learned a lot from the experts from Kobe University and PMDA.

Comments from Attendees

• The program was very helpful.
• This course is very useful for me for more understanding in regulatory sciences.
• This programme is good for GMP inspectors. The pre-learning VDOs are also very nice and provide basic knowledge for participants.
• Good workshops for keep knowledge on CMC reviews.
• This training program is very useful and provides basic, intermediate, and advance knowledge for anyone who is responsible for CMC review, GMP inspection, etc.
• It's great class to everyone. It can learning a lot of sharing from many countries.
• I learned a lot from this workshop. I will definitely recommend it to others.
• Definately!!
• The workshop is useful.
• Clearly understand the biopharmaceutical process.
• It's perfect.
• I learned a lot and I understood somethings I wasn’t clearly.
• Program is designed with latest updates and very informative.

Comments from Attendees

• The contents of the workshop are updated and the exhibitors showed an amazing topic domain.
• The workshop held was an excellent basis to learn about the subject and continue to deepen from here on. I hope they carry out more workshops of this type. Thanks.
• It's very interesting program.
• I am sure that the contents are beneficial to both CMC reviewers and GMP inspectors.
• Systematic learning from the fundametnal to the applications of the CMC knowledge is benefits to the reviewers.
• The content of this program is very useful for CMC review.
• Great training for me to know the critical conditions needed to be serious considered during CMC reviewing or GMP inspection.
• It's a great and informative seminar.
• It help me have a better understanding for biotherapeutics in many respects.
• Very informative, always on time, knowledgeable expert panels, platform is user-friendly, quality of information, quality of presentation, helpful and attentive staff. Everything is excellent apart from small drawback of no printable materials.
• The detail of the development of the topics is very important since many do not have direct experience in the manufacture of biotechnology drugs, as well as the availability of being able to see them more than once since they were recorded.
• The seminar increased my knowledge and I will put it into practice during the development of my activities.

Comments from Attendees

• Contents are very fruitable.
• This course offers the opportunity to introduce ourselves to the subject of biotech drugs, which not many of us are familiar with.
• I think is a well prepare curse, the material and the slides are great, specially for people with no expertise in biological products.
• It is useful for inspectors to realize the biological medical product process.
• The training materials are useful for newcoming inspectors.
• The workshop helps participants understand the CMC process and detailed critical procedures in biologic products, in addition, Mock GMP inspection provide a different view for CMC reviewers to review the CMC documents.
• The learner could get the whole picture of the manufacturing process of the biological products and the concept of the facility control under GMP.
• it's very informative, because this workshop is a good opportunity to learn about biopharmaceutical & GMP, completed with a great learning system, provided pre-recorded lessons, and a lively discussion with the experts. This workshop is also enjoyable. :)
• The training topics and contents are useful for knowledge sharing and enhance the understanding.
• Good and clear explanation of the biotherapeutics manufacturing process and the related GMP requirements.
• The topics were very helpful especially to CMC regulators like us. The things we have learned will help us evaluate documents better in terms of technicalities and concept.
• It was a very interesting training for the contents and methodology used.

Comments from Attendees

• I will recommend beginners inspector as well as reviewer team due to good input and knowledge.
• Insightful to combine both CMC and GMP topics as there are overlaps in these two topics.
• The course was well organized and coordinated. I enjoyed the course a lot.
• The workshop is a beneficial programme.
• I think the training was valuable in some ways for me, since I had a chance to ask about methods that I generally can't.
• Kobe has a training center to directly practice GMP inspection activities and develop CMC manufacturing.
• The workshop is very helpful in performing my work as a biologics GMP inspector.