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26-11-2019 (Singapore)

P40103 Packaging & Labelling in Pharmaceutical Industry
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Packaging & Labelling in Pharmaceutical Industry

26 – 27 November 2019 | Mandarin Orchard Hotel, Singapore

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overview

Key Learning Outcomes

  • International standards and regional perspectives on medicinal packaging & labelling (P&L)
  • The roles of P&L in mitigating drug supply chain risks
  • Key elements of successful track-and-trace and drug anti-counterfeiting systems
  • Important guidelines in drug packaging, storage, handling & transportation
  • Important guidelines in drug labelling and artwork
  • Key considerations in maintaining a GMP-compliant artwork process
  • Practical strategies for maximising patient adherence through P&L processes
  • Practical case studies: OTC, biosimilars, combination products, API products and others
  • Approaches for resourcing and auditing P&L suppliers
  • Technological advances and applications in P&L
  • Potential legal issues pertaining to labelling violations, contamination, recalls, marketing, medical affairs and more

 

Who Should Attend

This programme is essential to any technical, commercial and compliance executives involved in or making decisions on medicinal products’ registration, compliance, launches, distribution, including:

  • Packaging, Labelling & Artwork technicians
  • Pharma Supply chain & Distribution
  • Quality assurance
  • Regulatory affairs
  • Market Access
  • Relabelling, Repackaging
  • Production control
  • Operations
  • Serialisation Project management
  • Technology
  • Drug Marketing, Procurement & Distributors
  • Contract manufacturers
  • Packaging & Labelling technology providers

 

What Attendees Like About Our Life Science Programmes

Trainer has great experience & approach to teaching and offers substantial knowledge in end-to-end process for contract manufacturing

Lee Jong Nyung, TO Manager, Janssen

The programme includes good overview information on pharma strategies across the ASEAN region. I enjoyed the global drug trends discussion

Shahanar Sulaiman, Deputy Operations Director, Pharmaniaga Manufacturing Berhad

Instructor makes a complicated topic easier to understand. Great interaction with participants to discuss about projects, initiatives & market access

Christy Oi, Regional Financial Controller, IPSEN Pharma Singapore

I understand more on issues and challenges faced by RA professionals as well as packaging & labelling compliance across different countries

Beh Renlin, Senior RA/R&D Executive, Leung Kai Food Medical

The course enabled me to improve general understanding on Pharma regulations, as well as participate in active discussion with other trainees

Chng Kien Peng, Executive Director, Xepa-Soul Pattinson (S) Pte Ltd

pricing

Packages Price
2 Day TrainingSGD $3495Early Bird

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day training package only.
For Group Registrations, email register@ibcasia.com.sg or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer

Dr. Salma Michor, PhD, MSc, MBA, CMgr, RAC

Salma Michor is founder and CEO of Michor Consulting and Trade Services GmbH.

She has advised numerous global clients across Pharmaceutical, Medical and Food industries, including J&J, Novartis, Pfizer and Shire and many more.

Prior to Michor Consulting, Salma worked for Torrex-Chiesi (Chiesi Farmaceutici S.p.A); Wyeth Whitehall Export, and Croma Pharma GmbH and had been the Director of Global Supporting Operations – Medical Devices and Pharmaceuticals (Ophthalmology & Orthopedics) where she was in-charge of technical and leadership of four departments – including Regulatory Affairs and Compliance; Medical and Vigilance; Change Control and Life Cycle Management; as well as Packaging and Pharmaceutical editing. Her duties included overall leadership & management of human resources, budgeting and strategic planning, liaison with external contractors, doctors and customers in 60 countries worldwide. Here she also got first-hand experience with submission of clinical trials phases: I-III as well as turnaround management of post-Mergers and Acquisitions integration operations. Her specialties include:

  • Post-acquisition phase-out and closedown after M&As
  • Managing DCP registrations Consolidation of Multi-language labelling texts for pharmaceutical products and medical devices
  • Labelling compliance for drugs & food supplement
  • Authoring CMC sections for drug products or drug/device combination products
  • Preparing pharmaceutical and medical device companies for internal and FDA audits Managing large company-wide compliance projects (CAPA, GMP, ISO, etc)
  • Forming clinical and registration strategies for combination products
  • Preparing a medium sized company in a 3rd country for EMA, MHRA and AGES inspections and managing the whole biotech registration and clinical testing in the EU

Agenda

GUIDELINES IN MEDICINAL PACKAGING, LABELLING & ADVERTISING

  • International standards (ISO, GMP, GDP)
  • EMA/CHMP and FDA perspectives
  • EU practices on SmPC, package leaflets and product labelling
  • Falsified Medicines Directive (FMD) Compliance and potential applications in ASEAN
  • ASEAN harmonised labelling requirements and country-specific regulatory updates
  • Private labelling law

DRUG SUPPLY CHAIN RISKS

  • Drug supply chain integrity and control
  • Traceability, counterfeit & drug supply shortage
  • Facilifised medicines in Southeast Asia
  • Adverse drug events and medication errors

ANTI-COUNTERFEITING AND SUPPLY CHAIN VISIBILITY

  • Serialisation of Pharma Folding Cartons & Track-and-trace solutions
  • Countries’ regulation of process compliance
  • Key elements of a successful track-and-trace system
  • System validation, security, handling and maintenance

LABELLING & ARTWORK GUIDELINES

  • Creation of labelling from SmPC
    • Labels, PIL, label-leaflet variants, Patient package inserts’ (PIs) replacement and supplement
    • Difference between Generics/Rx/OTC labelling
  • Concept of readability and guidelines of readability testing
  • Serialisation requirements
  • Specific requirements
    • Formatting, quality, material, braille, symbols, multilanguage, storage information
    • Labelling in foreign countries

PACKAGING, STORAGE & HANDLING GUIDELINES

  • Creation of package
    • Primary, secondary & tertiary packaging
    • Packaging component specifications, materials, folds, carton, blisters
  • ISO 15378:2017, ISO 21976:2018
    • Specific requirements Safety, manufacturing efficiency, eco-conscious
    • Codes and verification of codes on packaging equipment
  • Mitigating damage in the supply chain
    • Breakage, spillage, sterility, impermeability, contamination-proofing, temperature range

IMPLEMENTING A GMP-COMPLIANT ARTWORK PROCESS

  • Packaging & labeling errors
  • Artwork lifecycle workflow
  • Content control and recordkeeping
  • SOPs and Change Control considerations
  • Minor and major variations submissions/reply to deficiency letters

CASE STUDIES: OTC LABELLING & PACKAGING

  • Self-medication and safety issues
  • Inconsistency and variability issues

PROMOTING PATIENT ADHERENCE THROUGH LABELLING & PACKAGING STRATEGIES

  • Data-driven insights on patient adherence
  • Key barriers and factors influencing adherence
    • Adherence packaging for patient compliance Multimed packaging
    • Medication therapy management best practices
  • Patient-centred prescription drug label

CASE STUDIES: NAMING, LABELLING FOR BIOSIMILARS

  • New FDA guideline
  • Documentation on immediate plastic packaging
    • Types of administration
    • Dosage forms
  • Labelling requirements:
    • Unique device identification
    • Instructions for use
  • Design reviews, verification, validation, document input/output data

AUDITING PACKAGING & LABELLING SUPPLIERS

  • Product quality, specification, cost & security of supply
  • ISO testing standards
  • Delivery time and speed-to-market considerations
  • Technical and quality agreement (TQA), Service level agreement (SLA)
  • Flexible resourcing approach

CASE STUDY: PACKAGING OF COMBINATION PRODUCTS AND MEDICAL DEVICES

MATERIALS, PACKAGING, STORAGE & HANDLING OF APIs

  • New FDA guidance on APIs packaging, repackaging, labeling & distribution

TECHNOLOGIES IN PACKAGING & LABELLING

  • Anti-counterfeiting
    • e-labels, self-destructive labels
  • Secure & Sustainable packaging
    • Biodegradable packaging
    • Pre-fillable syringes
    • Smart packaging sensors
  • Labeling & artworks
    • DNA authentication technology
    • Ink technology
  • RFID tags
  • Tamper-evident technology
  • Nanotechnologies & plastics
  • Blockchain

LEGAL ISSUES SURROUNDING THE ASIAN REGIONS

  • Contamination issues
  • Labeling violations
  • Statutory warnings
  • Unapproved prescription drugs
  • Recalls

 

when & where

26 - 27 Nov 2019

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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