Objective:

In order to improve the level of R & D and pharmaceutical manufacture in , to increase the international competitiveness of Chinese pharmaceutical products, and meanwhile facilitate the Quality Consistency Evaluation of Generic Drugs, we organized this seminar on Pharmaceutical preparation technology. This Seminar provides an updated comprehensive overview of the latest pharmaceutical manufacturing technologies for solid dosage forms through concise lectures over two days. Participants will be provided with useful insights and industry-relevant updated knowledge on the preparation and characterization of powders, granules and tablets together with latest advances in the associated manufacturing fields.

Who Should Attend: Personnel involved in R&D and manufacture of pharmaceutical products:  Production / QA / QC  Product formulation and development  Contract manufacturing  Regulators and marketers

Programme Sunday, 23 Oct 2016

Time Activity

13:30 – 20:30 Registration

Monday, 24 Oct 2016

Time Activity

07:30 – 08:30 Registration

08:30 – 08:50 Welcome address

08:50 – 09:40 Tools for Particle Size Reduction (Wilf Sangüesa, Idex- Quadro)

09:40 – 10:30 Wet Granulation to produce Granules and Pellets (Dilwyn Patterson, GEA)

10:30 – 10:50 Tea break

10:50 – 11:40 The Latest in Dry Granulation Technology (Scott Wennerstrum, Idex-Fitzpatrick)

11:40 – 12:30 Continuous Wet Granulation (Richard Steiner, GEA)

12:30 – 13:30 Group photo and lunch

13:30 – 14:20 Using Powder Rheometry to improve tablet Critical Quality Attributes (Tom Qin, Freeman)

14:20 – 15:10 Fluid Bed Granulation (Dilwyn Patterson, GEA)

15:10 – 16:00 Choice of Excipients in terms of Quality Consistency Evaluation of Generic Drugs (Xiaolong Chen, Meggle)

16:00 – 16:20 Tea break

16:20 – 17:10 Scale up - High Shear & Fluid Bed (Dilwyn Patterson, GEA)

17:10 – 18:00 PAT for Pharma Manufacturing (Richard Steiner, GEA)

18:00 – 18:30 Panel discussion

19:00 – 21:00 Networking dinner

Tuesday, 25 Oct 2016 Time Activity

08:00 – 08:50 Basics on Tablet Compaction (Richard Steiner, GEA)

08:50 – 09:40 Tablet Compression Tooling Options (Robert Sedlock, Natoli)

09:40 – 10:30 Compression simulator – Essential R&D tool in tablet development (Bruno Leclecrq, MedelPharm)

10:30 – 10:50 Tea break

10:50 – 11:40 Continuous Direct Compaction (Richard Steiner, GEA)

11:40 – 12:30 Continuous Coating (Benjamin Murugesu, O’Hara)

12:30 – 13:30 Lunch

13:30 – 14:20 Recent Innovations in Pharmaceutical Coating (Zhu Ying, Colorcon)

14:20 – 15:10 Design of Controlled Release Dosage Forms (Henry Han, Evonik)

15:10 – 16:00 Compaction of MUPS Tablets (Paul Heng, NUS)

16:00 – 16:20 Tea break

16:20 – 17:10 Containment Coating (Benjamin Murugesu, O’Hara)

17:10 – 18:00 Extraction and Spray Drying (Dilwyn Patterson, GEA)

18:00 – 18:30 Panel discussion

End of seminar Closing remarks

Biography of Speakers

Xiaolong Chen joined MEGGLE Group in China since 2012 as a technical director. He oversees the technical applications of Meggle lactoses in China. Apart from routine troubleshooting for formulators, Dr Chen manages an application laboratory for tabletting. Prior Meggle, Dr Chen was an engineer at Harro Hoefliger GmbH for 5 years, specialising in precise powder filling processes, commonly related to dry powder inhaler production. Dr. Chen obtained his PhD in pharmaceutical technology institute at Christian-Albrecht University in Kiel, Germany. He studied on processing of pharmaceutical powder with fine particles. Dr Chen graduated from the Chinese Pharmaceutical University in Nanjing with a degree of pharmaceutical technology. Currently, he is a member of International Association for Pharmaceutical Technology.

Henry Han is the Technical Director of Health Care, Evonik Specialty Chemicals (Shanghai). He is a Senior Engineer (Prof.), an expert of pharmaceutical excipient, and is a member of the Shanghai Pharmaceutical Association. Before Evonik, Henry worked for Tianjin Zhongxin Pharma group and Colorcon, China. He has more than 20 years’ experience in pharmaceutical industry, focus on excipient research and application in the new dosage form.

Paul Heng has a pharmacy degree and PhD from the National University of Singapore in 1985. He has since joined the National University of Singapore and is currently an associate professor with the Department of Pharmacy. He is also the Principal Investigator for GEA-NUS Pharmaceutical Processing Research Laboratory, a research laboratory focused in process and product development related to pharmaceutical technology. His research interest is in powders, multiparticulates, controlled release systems and tabletting, among others. He has over 240 international refereed research journal articles, several book chapters and patents, and is the editor-in-chief of the Asian J Pharm Sci and is in the editorial boards of several pharmaceutics research journals.

Bruno Leclercq is a senior pharmacist working in business development at Medelpharm, headquartered in Lyon, France, an international company dedicated to a continuous search for innovative solutions in powder compression and processing technologies in order to create the ultimate tool for scientists in R&D. MedelPharm’s renowned STYLCAM/ STYL’One Tableting Instrument has become an industry standard for compaction simulation and challenging powder characterization as well as small scale development in the pharmaceutical industry. Bruno is an experienced pharmaceutical technical Manager with extensive knowledge in solid form technology and processes. He can look back to more than 15 years of International experience in meeting, advising and solving customers’ formulations and production problems in Europe, SEA und the US. Benjamin Murugesu is the Vice President, Global Business Development of O’Hara Technologies Inc., a specialist company in tablet coating and the innovator of continuous coating technology, based in Toronto, Canada. Mr Murugesu is British/Canadian trained in mechanical engineering and management, Masters (MCGI) from London, UK. He has over 40 years of experience in mechanical engineering, specializing in machine and process design. He has been awarded 3 worldwide patents for his novel inventions in process solutions for the pharmaceutical industry and also has several innovations to his credit. He has been associated with the pharmaceutical industry for more than 25 years, focused in solid dosage and related manufacturing. Ben is certified senior member, Institute of Industrial Engineers, senior member, Society of Manufacturing Engineers, Ontario Certified Engineering Technicians and Technologists. He is also a member of American Association of Pharmaceutical Scientists and ISPE.

Dilwyn Patterson was educated at the University of Manchester, UK where he graduated with a PhD in materials science. He currently is the Area Sales Manager of GEA Pharma Solutions and is responsible for the Japan, South Korea and Taiwan markets. He also provides technical support for the design and operation of batch processing equipment and systems. His role also incorporates on site trouble shooting and providing process assistance. He has worked with the pharmaceutical industry for over 25 years supplying granulation, drying, pelletizing and coating equipment and systems and has gained considerable experience in each of these technologies.

Tom Qin worked at Shanghai Institute of Ceramics, Chinese Academy of Sciences with interest in research of crystal materials and devices after he graduated from university in 1984. He holds a diploma in management programme from China-Europe International Business School. Prior to joining Freeman Technology China as Chief Representative, he worked in the field of particle characterization and analysis for 20 years with positions from Customer Support and Applications Manager to General Manager. He gained strong and valuable experience in pharmaceutical materials and powders characterization in recent decades.

Wilf Sangüesa, P.Eng. joined Quadro Engineering in 2005 and has had Product Management responsibilities for both Solids and Liquids Divisions. For the last three years he has been responsible for Roll Compaction and Milling technologies as the Fitzpatrick/Quadro Global Pharma Segment Product Manager. He received his Bachelors of Mechanical Engineering from the University of Western Ontario in 1991 and is a member of the Association of Professional Engineers (PEO). Wilf started his career serving the Chemical, Petrochemical and Pulp and Paper industries, and has had tenures in industrial material handling equipment and project management. Wilf frequently presents at international Industry and Academia Pharma focused seminars. Robert Sedlock is the Director of Technical Training and Development for Natoli Engineering Company. He has been serving the industry for over 18 years in the tablet compression arena. His early experience spans strain gauge force measurement technology and data acquisitions systems. Mr. Sedlock has many published technical papers in the field of tablet compression. Areas of expertise include instrumentation systems, formulation optimization, compaction analysis and scale up. His current responsibilities include solid dosage training and consulting services in the development, scale up and manufacturing environments. Mr. Sedlock is currently involved in many training seminars hosted by universities worldwide with a majority of his efforts at Natoli Institute of Industrial Pharmacy Research & Development located at Long Island University Arnold & Marie Schwartz College of Pharmacy and Health Sciences in Brooklyn, New York.

Richard Steiner was educated at the University of Applied Sciences in Nuernberg and the FU University of Berlin and graduated as a Mechanical Engineer, MBM and MBA. He worked in different management positions during his times at Leistritz and Raumedic and is considered as a B2B marketing specialist as well as a hot melt extrusion process expert. In 2012 he joined GEA Pharma Systems as a Business Development Manager for the Continuous Processing Equipment to manufacture OSD products. He contributed papers and chapters on many international conferences and scientific textbooks. His favorite topic is the implementation of continuous processing in the pharma industry. Beside the business strategy consultation, he covers today also considerable process knowhow from continuous dispensing, blending, granulation, extrusion, drying, tableting to coating.

Scott Wennerstrum is the Technical Director of The Fitzpatrick Company, IDEX Material Processing Technologies. Scott has been with the Fitzpatrick Company for over 30 years in a variety of positions. Currently as Technical Director, Scott’s team is responsible for pre-sale and post-sale process and technical support, including lab testing, technical service, FATs and SATs, as well as commercial support for sales and marketing. Scott received an MBA in 1990 from Illinois Institute of Technology and a BS in Mechanical Engineering from the University of Tulsa in 1983.

Ying Zhu is the Technical Manager for Colorcon China, responsible for providing technical assistance to customers for their immediate and modified release solid dose formulation development, trouble shooting and small scale and commercial scale trial support and providing good technical management and support to ATMs and technical service lab. Prior to joining Colorcon in 2000, Zhu Ying was a teacher in China Pharmaceutical University. Zhu Ying obtained Ph.D. in pharmacy from Pharmaceutical and obtained bachelor and master degree in Pharmaceutics from China Pharmaceutical University.

Registration Fee &Payment information

Participant Fees

Industry affiliates/Government/Academics RMB 1500

Student RMB 800

By Bank Transfer Information

BANK CHINA CONDTRUCTION BANK BRANCH SHENYANG TONGHUI SUBBRANCH

ADDRESS OF BANK No. 141 11TH Road Shenyang City, Liaoning Province, China

BENEFICIARY Shenyang Pharmaceutical University

ACCOUNT NO. 21001530008059269025

CONTACT PERSON Lijuan Fu (the head of the Department of Finance)

TELEPHONE NUMBER 024-23986132

Directions to the Wanda Vista Shenyang (Hotel)

Address：No. 17-5 Yingpan Street, , Shenyang, Liaoning Tel: (86-24) 31628888

Transportation:

From Shenyang Taoxian International Airport: By taxi: Taxi fare from the airport is about 45 RMB. Outside the rush hour, the taxi ride will take about 30 minutes.(16km)

By Hunnan Modertrams : At the Taoxian Airport station of line 2, get on the train bound for Taoxian Airport station to the Xinglong Daaolai station, then go off the train at Yifeng Guangchang station. Walk along Hunanzhong Street and it will take 10 mins to get to the Wanda Vista Hotel. Under normal conditions the ride will take about 1.5 hours.

From Shenyang North Railway Station: By taxi: Taxi fare from the railway station to the Wanda Vista Hotel is about 25RMB. Outside the rush hour, the taxi ride will take about 26 minutes. (12 km)

By subway: At the Shenyang North Railway Station, take the subway line 2 which is bound for Santaizi Station to the Yingpan Jie station, then go upstairs and leave through Exit A. Walk along Yingpan North Street and it will take 10 mins to get to the Wanda Vista Hotel. Under normal conditions the ride will take about 45 minutes.

From Shenyang Railway Station: By taxi: Taxi fare from the railway station to the Wanda Vista Hotel is about 25 RMB. Outside the rush hour, the taxi ride will take about 25 minutes. (11.2 km)

By subway: At the Shenyang Railway Station, take the subway which is bound for Shisanhao Jie Station to the Qingnian Dajie station, then transfer to subway line 2 which is bound for Santaizi Station to the Yingpan Jie station go upstairs and leave through Exit A. Walk along Yingpan North Street and it will take 10 mins to get to the Wanda Vista Hotel. Under normal conditions the ride will take about 40 minutes.

Attachment: Registration Form

Registration Form Pharmaceutical Technology Seminar 2016 Wanda Vista Shenyang Hotel, China 24-25 Oct, 2016

(please fill in and tick the appropriate boxes)

Full name: Dr. ☐ First: Family: Mr ☐ Ms ☐ Institution / Company: Address:

Tel/Mobile: E-mail:

Regular Student Registration fee: ☐ 1500 RMB ☐ 800 RMB Add: ☐ 200 RMB, Networking dinner on 24 Oct, 2016 Total remitted: ______RMB Payment ☐ By bank transfer BANK INFO: CHINA CONDTRUCTION BANK LIAONING BRANCH SHENYANG TONGHUI SUBBRANCH BANK ADDRESS: No. 141, 11th Road, Shenhe District, Shenyang, Liaoning, China BENEFICIARY: Shenyang Pharmaceutical University (P.S. Pharm Tech Seminar) ACCOUNT NO.: 21001530008059269025 (Payment receipt to be shown, if required) ☐ On-site registration payment Title in invoice to be issued:

Accommodation: Wanda Vista Shenyang Hotel (Conference site) Please select Yes ☐ Room Type: ☐ Double room No ☐ (500RMB/day, with breakfast) Check in date: ☐ Twin room Check out date: (550RMB/day, with breakfast) Room booking is guaranteed only if received before 16th Oct, 2016

Note: Please send completed registration form to Email: [email protected]; [email protected]