The 2nd Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices

* The 2nd Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices concluded.

Summary

“The 2nd Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices” was held cohosted by  Pharmaceuticals and Medical Devices Agency (PMDA), Agência Nacional de Vigilância Sanitária (ANVISA), and Japan External Trade Organization (JETRO).
 The 1st seminar was held in São Paulo, Brazil, in August 2014. The second seminar was held for the first time in Tokyo as follows and presentations by professionals of the regulation of medical area in Brazil and Japan were delivered to the public.
 

Host and Support

Host
Agência Nacional de Vigilância Sanitária (ANVISA)
Japan External Trade Organization (JETRO)
Pharmaceuticals and Medical Devices Agency (PMDA)

Support

The Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ)
The Japan Federation of Medical Devices Associations (JFMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)

 

Date

September 10th, 2015
 

Venue

JETRO, 5F, Exhibition Hall
Ark Mori Building, 12-32, Akasaka 1-chome, Minato-ku, Tokyo

 

Number of Attendees

approximately 160
 

Program

9:00 - 9:40

Welcome Speech

• Dr. Tatsuya Kondo, Chief Executive, PMDA

Opening Remarks

• Mr. Katsunori Hara, Vice-Minister for the Ministry of Health, Labour and Welfare (MHLW)
• Dr. Jarbas Barbosa, Director President, ANVISA
• Mr. Hiroyuki Ishige, Chairman and CEO, JETRO
• Mr. Masafumi Nogimori, President, The Japan Federation of Pharmaceutical Manufacturer's Associations (FPMAJ)
• Mr. Fumio Suzuki, Vice President, The Japan Federation of Medical Devices Associations (JFMDA)
• Mr. Joffre Moraes, Regulatory Affairs Strategy Manager, Associação Brasileira da Indústria de Artigos e Equipamentos Médicos, Odontológicos e de Laboratórios (ABIMO)

 

9:40 - 9:50
Photo Session

 

9:50 - 11:00
Making Japanese and Brazilian Industries Closer
Moderator: Keiya Iida, Assistant Minister for Promotion of Healthcare Industries and Global Expansion of Healthcare, MHLW

• Updates from JETRO São Paulo office
  Mr. Yasuhiro Ishida, Director Presidente, JETRO SÃO PAULO
• Updates from Medical Devices Association
  Mr. Carlos Alberto Pereira Goulart （Executive President, Associação Brasileira da Indústria de Alta Tecnologia de Produtos para Saúde; ABIMED） & Mr. Joffre Moraes （Regulatory Affairs Strategy Manager; ABIMO）
• Q & A

 

11:00 - 11:20
Coffee Break 


11:20 - 13:05
Enhancing Review Efficiency
Moderator: Dr. Toshiyoshi Tominaga, Associate Executive Director (for International), PMDA

• Medical Devices
  Mr. Bruno Rios, Superintendent of Inspection, ANVISA
  Mr. Yasutaka Watanabe, Director, Office of Medical Devices III, PMDA
• Pharmaceuticals
  Mr. Naoto Kato, Deputy Office Director, Office of Review Management, PMDA
  Ms. Meiruze Freitas, Superintendent of Medicines, ANVISA
• Pannel Discussion

 

13:05 - 14:25
Lunch Time

 

14:25 - 16:15
QMS/GMP System and International Collaboration   
Moderator: Dr. Shingou Sakurai, Office Director, Office of Manufacturing/Quality and Compliance, PMDA

• Medical Devices (Japan)
  Ms. Naoko Sato, Deputy Director, Office of Manufacturing/Quality and Compliance, PMDA
• Pharmaceuticals (Japan)
  Dr. Ryoko Naruse, Director, Office of Manufacturing/Quality and Compliance, PMDA
• Medical Devices and Pharmaceuticals (Brazil)
  Mr. Bruno Rios, Superintendent of Inspection, ANVISA
• Panel Discussion

   

16:15 - 16:45
Coffee Break

 

16:45 - 17:45
Pharmaceutical Regulations of Advanced Therapy
Chair: Dr. Nobumasa Nakashima, International Planning Director (c/o Evaluation and Licensing Division), MHLW

• Advanced Therapies and ANVISA's experience of compliance of new drugs
  Ms. Meiruze Freitas, Superintendent of Medicines, ANVISA
• Advanced Therapies and experience on SAKIGAKE for approval of innovative drugs
  Mr. Kazuhiko Mori, Director, Evaluation and Licensing Division, MHLW

 

17:45 - 17:55
Closing Remarks

• Dr. Jarbas Barbosa, Director President, ANVISA
• Mr. Kazuhiko Mori, Director, Evaluation and Licensing Division, MHLW