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【Registration open】Invitation for the 2nd Session of POTENT Compound Safety Boot Camps, June 30-July 1, 2023
Source: | Author:碧小瑞 | Published time: 2023-03-31 | 189 Views | Share:







Once the potent compound safety training news was released, we have received very positive responses and many professionals from the pharmaceutical and chemical industries have signed up the training course, and now enrollment for this session is closed. In response to strong interests in this course and many more requests from clients, the second session of this course is scheduled from June 30th to July 1st, 2023. Welcome to join this practical, highly informative and valuable training course!




The emergence of the COVID-19 pandemic highlights the importance of health. In recent years, more and more drugs are at the stage of research and development and mass production. Toxicities of many of them, such as antibody drug conjugates (ADC), are very high. How to manage its risk in R&D and mass production is an important issue. Because of this reason, we have often received the following questions from pharmaceutical supply chain companies:




How to identify the risks of highly active pharmaceutical ingredients and determine its occupational exposure band (OEB)?


How to develop the internal occupational exposure limit (OEL) (OEL) for highly potent compounds?


How to perform equipment containment performance (SMEPAC) testing? How to interpret its testing results?


How to evaluate whether the existing facilities meet the production requirements of highly active pharmaceutical ingredients with classification in OEB 4 or OEB 5?


How to control the exposure level of highly active pharmaceutical ingredients?


How to determine the acceptable surface limit (ASL)?


How to determine the acceptable daily exposure (ADE) or the permitted daily exposure (PDE)?


How to protect workers for handling highly potent compounds during the R & D stage?


How to establish an effective highly potent compound management system?


In order to answer such questions as stated above and improve safety risk management level of highly potent compounds in pharmaceutical supply chain enterprises, we are pleased to hold the " Potent Compound  Boot Camp" course in China with SafeBridge®, a world-renowned drug safety assessment consulting firm.

 

In 2019, SafeBridge® and us successfully held a training session on a similar theme in Shanghai, which had received a very positive feedback from our training attendees.  In this upcoming training, we will bring the current cutting-edge management experience and best practices to the Chinese students, empower and equip them with the necessary professional skills to help companies manage the risks of highly active pharmaceutical ingredients, and ensure enterprises are operating at sustainable mode and at acceptable minimum risk level.





Potent Compound Safety Boot Camps







The SafeBridge Regulatory & Life Sciences Group is the premier resource for high-level safety and health consulting to the pharmaceutical and biotechnology industry. Founded in 1997, the team includes more than 50 professionals who provide the Potent Compound Safety Triangle® of services, namely, toxicology, industrial hygiene, and industrial hygiene analytical chemistry. Its specific expertise is in the recognition, evaluation, and control of potential worker exposure and product safety issues associated with the handling of potent and highly potent drug substances and drug products. In addition to the work we have traditionally performed for the pharmaceutical industry, we also provide services related to the registration and approval of food and beverage ingredients and biocides, general industry industrial hygiene services, quality assurance of non-clinical toxicology studies, and regulatory submissions for the registration of industrial and specialty chemicals for global trade (e.g., REACH, TSCA). The well-known control banding/OEB was first developed by SafeBridge experts.  Safebridge® popular signature course “Potent Compound Safety Boot Camp” was successfully held in Shanghai, Raleigh, Chicago, Boston, Berlin, Liverpool, Santiago, Hyderabad, etc.

 


COURSE CONTENT


A combination of lectures, exercises, and videos to better understand the scientific and systematic approach (the “hardware” and the “software”). Course materials include a binder with “white papers”, literature, and other references. All slides presented will be in English with Chinese translation.

Programs & Procedures

The “Software”

• Case Studies of Occupational Exposure in Lab and Manufacturing Environments, including interactive scenarios

• Incorporating Potent Compound Safety elements into project teams

• Occupational Health Categorization (OHC)

• Occupational Exposure Limits (OELs)

• Industrial Hygiene exposure assessment, including an exercise

• Permitted Daily Exposure (PDE) determination for product quality and cross-contamination purposes


Containment & Controls

The “Hardware”

• Facility Design and Controls

• Process Design and Controls

• Traditional and Advanced Controls

• Laboratory & Manufacturing Scale Controls

• Available Exposure Data on:

    • Flexible Containment

    • Ventilated Enclosures

    • Isolators

• Linking Categorization and OEL with containment and controls, including an exercise


Course Features


The course format is a combination of explanation, practice, and video, with materials in both Chinese and English.


Instructors


Allan W. Ader, PHD, DABT, and Managing Director, SafeBridge®: Allan has over 20 years of experience in toxicology, risk assessment, and industrial hygiene. He has an extensive background in evaluating complex environmental, health and safety issues, and in developing solutions and programs. For more about Allan, please visit our website at www.safebridge.com.

 

Anne Chappelle, Ph.D. DABT, Dr. Chappelle is a Senior Managing Toxicologist at SafeBridge Regulatory and Life Sciences Group and has 25 years of experience as a toxicologist in the pharmaceutical and chemical industry performing risk assessments and generating data that serves to minimize potential adverse outcomes to workers, consumers, and the environment. She graduated from University of Delaware in 1991 with a bachelor degree in arts and sciences, and holds a Ph.D. in Pharmacology and Toxicology from St. Joseph’s University.  She is certified by the American Board of Toxicology. Anne is passionate about science communication; she is the current co-host of the Society of Toxicology interview podcast Adverse Reactions (www.adversereactionspodcast.com), and has appeared in Tech Support answering poison questions from Twitter for Wired Magazine.

 

David Lu, Ph.D., CSP, CIH, Managing Director, Beeree: Dr. Lu has 20 years of work experience in the environmental, health and safety profession, including 13 years of experience in the US. His experience has been enriched with his work from various trades, such as pharmaceuticals, electronics, consumer product manufacturers, construction, institutional and research & development, and energy and petroleum industries. Dr. Lu has successfully delivered hundreds of health and safety consulting and engineering projects in more than 20 countries in Asia, Africa, Europe, Middle East, North America, and South Africa, and has developed more than 20 training packages on various EHS topics, and delivered the training courses to more than 3000 EHS professionals globally. For more about Dr. Lu, please visit our website at www.beeree.com. 



Who Should Attend



  • Pharmaceutical and chemical plant EHS professionals    

  • Facility and Process engineers     

  • Pharmaceutical R&D and safety coordinators    

  • Industrial Hygienists

  • Safety Professionals

  • Environmental Engineers

  • Pharmaceutical QA and QC personnel

  • Plant managers

 

Class Schedule


Date: June 30-July 1, 2023

Location: Shanghai

Cost: $ 1500/person (10500 RMB/person)

Early bird registration price: $ 1250/person (8750 RMB/person)

Deadline for early bird price discount: May 19, 2023

Training costs include two -day training, lunch, course materials, and globally recognized training certificates issued by SafeBridge®


Curriculum


After completing this course, you can get 13 CIH & CSP continuing education hours. It can be used for CIH applications or for CIH & CSP certificate maintenance.

  • Equal to 1.3 CSP continuing education hours

  • Equal to 2.17 CIH maintenance credits

 

Methods of registration



 Click "Read the original text" to get the course brochure and registration form.

Or send an email to us, we will send you the course brochure and registration form.


 

Registration consultation


Mail:henry.zhu@beeree.com

Tel:0571-88391363 


 



Scan the QR code to add our public account: “Bi-Xiao-Rui” for course questions