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    ICH Q1 Stability Training Program MY 2019 - Brochure - 07 2019 PDF

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    Sih Atii
    This 3-day training seminar on ICH stability guidelines will be held from August 6-8, 2019 in Selangor, Malaysia. It is organized by the Pharmaceutical Association of Malaysia and supported by the National Pharmaceutical Regulatory Agency. The seminar will provide an overview of ICH stability guidelines and expectations for stability testing, with sessions on specific guidelines like ICH-Q1A, Q1C, Q5C, and the local regulatory perspective from NPRA. Participants will learn a risk-based approach and gain an understanding of key concepts like bracketing, matrixing, and life cycle management in relation to stability testing.

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    ICH Q1 Stability Training Program MY 2019 - Brochure - 07 2019 PDF

    Uploaded by

    Sih Atii
    117 views4 pages
    This 3-day training seminar on ICH stability guidelines will be held from August 6-8, 2019 in Selangor, Malaysia. It is organized by the Pharmaceutical Association of Malaysia and supported by the National Pharmaceutical Regulatory Agency. The seminar will provide an overview of ICH stability guidelines and expectations for stability testing, with sessions on specific guidelines like ICH-Q1A, Q1C, Q5C, and the local regulatory perspective from NPRA. Participants will learn a risk-based approach and gain an understanding of key concepts like bracketing, matrixing, and life cycle management in relation to stability testing.

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    ICH-Q1-Stability-Training-Program-MY-2019_Brochure_07-2019.pdf

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    This 3-day training seminar on ICH stability guidelines will be held from August 6-8, 2019 in Selangor, Malaysia. It is organized by the Pharmaceutical Association of Malaysia and supported by the National Pharmaceutical Regulatory Agency. The seminar will provide an overview of ICH stability guidelines and expectations for stability testing, with sessions on specific guidelines like ICH-Q1A, Q1C, Q5C, and the local regulatory perspective from NPRA. Participants will learn a risk-based approach and gain an understanding of key concepts like bracketing, matrixing, and life cycle management in relation to stability testing.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    117 views4 pages

    ICH Q1 Stability Training Program MY 2019 - Brochure - 07 2019 PDF

    Uploaded by

    Sih Atii
    This 3-day training seminar on ICH stability guidelines will be held from August 6-8, 2019 in Selangor, Malaysia. It is organized by the Pharmaceutical Association of Malaysia and supported by the National Pharmaceutical Regulatory Agency. The seminar will provide an overview of ICH stability guidelines and expectations for stability testing, with sessions on specific guidelines like ICH-Q1A, Q1C, Q5C, and the local regulatory perspective from NPRA. Participants will learn a risk-based approach and gain an understanding of key concepts like bracketing, matrixing, and life cycle management in relation to stability testing.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 4

    Training Seminar on ICH Stability Guidelines (ICH-Q1)

    in collaboration with NEU and supported by National Pharmaceutical Regulatory Agency (NPRA)

    NPRA

    Date: August 6th – 8th, 2019


    Venue: Dorsett Grand Subang, Jalan SS 12/1, 47500 Subang Jaya, Selangor, Malaysia

    Learning Objectives:

    • Understand the and expectations on stability studies and appreciate use of risk
    management
    • Describe the stability testing of drug substances and products as outlined in the
    ICH-Q1A(R2) and ICH Q5C guidelines.
    • Explain the importance of photostability testing of new drug substances and
    products in ICH-Q1B.
    • Define stability testing for new dosage forms as outlined in ICH-Q1C.
    • Demonstrate the bracketing and matrixing ICH-Q1D
    • Evaluation used for stability testing as explained in ICH-Q1E.
    • Describe the WHO guidelines on stability testing of active pharmaceuticals in
    climatic zones III and IV, which replaced ICH-Q1F.
    • Describe Life Cycle Management for stability changes (ICH Q12)
    • Current practice in Malaysia

    PhAMA: Pharmaceutical Association of Malaysia


    NEU: Northeastern University, Burlington, Massachusetts, USA
    NPRA: National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia
    Day 1: Tuesday, August 6, 2019

    Session 1: Introduction to ICH and Stability Testing

    08:30-09:00 30’ Registration (light refreshments)

    09:00-09:10 10’ Welcome PhAMA

    09:10-09:20 10’ Opening Remarks NPRA

    09:20-09:30 10’ Group Photo

    1.1 ICH introduction and overview of ICH stability


    09:30-10.15 45‘ Jared Auclair (NEU)
    guidelines and its Importance.
    10:15 –
    15’ Coffee Break Networking
    10:30
    1.2 ICH-Q1A(R2) and ICH-Q1C:
    - Stability Testing of Drug Substances and Products
    Dinesh Khokal (Amgen)
    10:30-12:00 90’ Q1A(R2);
    Chi-wan Chen (Pfizer)
    - Stability Testing for New Dosage Forms (Q1C) with
    CASE STUDY

    Session 2: Setting the scene


    12:00-13:00 2.1 A science and risk-based approach to utilize stability
    data to set specifications
    Proposed Topics to be covered in this part:
    • Importance of Degradation studies – selecting the
    right degradation products to monitor
    • Building a body of knowledge - Importance of
    primarily studies: clinical material, predictive
    60’ Kayla Woodlief (Biogen)
    stability, formulation compatibility studies
    • Batch selection – What criteria to use for Drug
    Substance and Drug Product
    • Setting Specifications based upon release data
    and stability data
    • Impact on Product shelf life and In-Use period

    13:00-14:00 60’ Lunch

    2.2 WHO - Stability testing of active pharmaceutical


    14:00-15:10 70’ ingredients and finished pharmaceutical products Kayla Woodlief (Biogen)
    (replaces ICH-Q1F)

    15:10-15:45 35’ 2.3 In-use stability studies Open


    15:45-17:00 75’ 2.4 ICH-Q1E: Evaluation for Stability Data Chi-wan Chen (Pfizer)

    All Speakers &


    17:00-17:15 15’ Q&A Session
    NPRA Representatives

    17:15-17:30 15’ Coffee Break Networking

    Day 2: Wednesday, August 7, 2019

    Session 3: Specific expectations

    08:30-09:00 30’ Coffee and Breakfast Networking

    German Lastra (Amgen)


    09:00-10:15 75’ 3.1 ICH-Q5C: Stability of Biotechnology products
    –

    10:15-10:30 15’ Coffee Break Networking

    3.2 ICH-Q1B: Stability Testing: Photostability Testing of


    10:30-11:30 60’ Open
    New Drug Substances and Products with CASE STUDY

    3.3 ICH-Q1D: Bracketing and Matrixing Designs for


    11:30-12:45 75’ Open
    Stability Testing of New Drug Substances and Products

    12:45-13:45 60’ Lunch

    Open
    13:45-15:15 90’ 3.4 Risk Based Predictive Stability

    15:00-15:15
    15’ Coffee Break Networking

    3.5 Science based harmonized regulations for stability


    data and its relevance to patients: Industry and
    Regulator Perspective
    15:15-16:45 90’ Quan Yang (Merck)
    Case Studies: Risk Based Evaluation of stability
    (totality of the data, atypical stability data, etc.)

    All Speakers &


    16:45-17:15 30’ Q&A Session
    NPRA Representatives

    Day 3: Thursday, August 8, 2019

    08:30-09:00 30’ Coffee and Breakfast Networking

    3.6 Science based harmonized regulations for stability


    data and its relevance to patients: Industry and
    09:00-10:15 75’ Cedric Strassel (ROCHE
    Regulator Perspective
    Case Studies: Risk Based Evaluation of stability
    (totality of the data, atypical stability data, etc.)

    10:15-10:30 15’ Coffee Break Networking


    3.7 ICH Q12 Life Cycle management (in relation to
    10:30-11:30 50’ German Lastra (Amgen)
    Stability)
    3.8 Presentation on local perspectives:
    • Current practice in Malaysia
    • Expectations for submission – Shortcomings, Do’s & • Dr Seetha, NPRA
    11:30-12:20 60’ Don’ts etc.
    • Comparison with ASEAN-MY requirements
    • updates in ASEAN Guideline on Stability Study of
    Drug Product (R1)
    All Speakers &
    12:20-12:50 30’ Final Q&A Session
    NPRA Representatives

    12:50-13:00 10’ Closing Remarks Jared Auclair (NEU)

    13:00-14:00 60’ Lunch

    Registration details
    Please register via the online registration form at
    https://docs.google.com/forms/d/1YOOzV6AGpHtvnVsxfDVvhAsxKxP3N9doCdVpJyu3rMY/vi
    ewform?edit_requested=true
    Participation is on a first-come-first-served basis and registration will close by 17th July
    2019. Please contact PhAMA Event secretariat MPA SDN BHD at events@phama.org.my or
    janice@phama.org.my if you need any assistance. Registration Fee for industry is RM 1800.

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