BioPharma Talk, Product Quality Assurance in BioPharmaceutical Manufacturing

Tanggal Posting : Jumat, 9 Agustus 2019
Dibaca : 88 Kali

ISPE Indonesia In Collaboration with MERCK. Biopharmaceuticals are manufactured are complex. This event allows you to review global regulatory requirement and challenges, concerns points on developing biosimilar product until commercial process and explore testing, studies and emerging technology. Lets get started.

Speakers:

  • Martin Wisher, PhD. (Senior Director of Regulatory Affairs, BioReliance Services, Merck Life Science)
  • Edmund Ang, PhD. (Principal Scientist BioReliance, APAC Merck Life Science)
  • Azaz Rulyaqien (Senior Technology Manager for core Technologies Indonesia, Pakistan and Philipines)
  • Christopher Sweeney (A Biopharma Professional Kalbe Farma)

Who Should Attend: Profesionals, Managers, Staf QA, R&D, Business Development, Regulator, etc.

FEE Registration: ISPE Member: Rp 600.000. Non Member: Rp 900.000.

VENUE: TITAN Center Jl. Boulevard Bintaro Blok B7/B1 No.5 Bintaro Jaya Sektor 7, Tangerang 15224

REGISTRATION: ISPE Indonesia Affiliate Secretariat. Titan Center, Jl Boulevard Bintaro Blok B7/B1, Bintaro Jaya Sektor 7, Tangerang 15224. Telp.: +62 21 7452673. Fax: +62 21 7452614. secretariat.ispeind@gmail.com

PLEASE REGISTER BEFORE AUGUST 29, 2019. Rekening ISPE Indonesia,BCA Cabang Sentra Menteng Bintaro, Nomor: 6800-762888.

Note:

  • Fill in the attached registration form and transfer evidence to ISPE indonesia Secretariat
  • Member registration could not be replaced by non-member without additional fee
  • No refund for cancellation after August 29, 2019
  • Attendees will obtain SKP from IAI

Monday, 2 September 2019

  • 08.30 - 09.00: Welcome & Registration (ISPE Indonesia)
  • 09.00 - 09.45: Session 1: Regulation for Biosimilar in Indonesia (BPOM)
  • 09.45 - 10.15: COFFEE BREAK
  • 10.15 - 11.15: Session2: Review of Global Regulatory Requirements for Recombinant Proteins and Biosimilars (Martin Wisher, PhD.)
  • 11.15 - 12.15: Session 3: Cell line Characterization, Genetic Stability Study, VC & LRT UBH (Edmund Ang, PhD.)
  • 12.15 - 13.15: ISHOMA
  • 13.15 - 14.00: Session 4: Challenges in Development and Commercialiszation of Biosimilar (C. Sweeney)
  • 14.00 - 15.00: Session 5: Product Characterization and Stability Studies (Martin Wisher, PhD.)
  • 15.00 - 15.30: COFFEE BREAK
  • 15.30 - 16.00: Session 6: Emerging technologies for bioreactor safety (Azaz Rulyaqien)
  • 16.00 - 16.45: Q & A /Panel Discussion Closing (All & ISPE Indonesia).

Related Link
Contact Us

ISPE Indonesia Affiliate Secretariat

Website : www.ispeindonesia.org

alamat Titan Centre
Jln. Boulevard Bintaro, Block B7/B1 No.5 Bintaro Jaya, Sektor 7
Tangerang 15244, Indonesia
telp +62 21 745 2673
fax +62 21 745 2614
email info@ispeindonesia.org

ISPE Headquarters

Website : www.ispe.org

alamat 600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609 USA
telp +1-813-960-2105
fax +1-813-264-2816
email ask@ispe.org
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