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02-11-2020 ( Live Online)

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Live Online: Packaging & Labelling in Pharmaceutical Industry

2 – 5 November 2020 | 4-Day Live Online | 1:30 pm – 5:30 pm (SGT)

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REGISTER 2 DELEGATES & THE 3RD COMES FREE!

overview

About the Course

Packaging, labelling (P&L) & artwork processes play significant roles in maintaining medicinal products’ quality, promoting safe use, patient adherence and responsible distribution. With various risks threatening drug supply chain integrity (drug traceability, counterfeiting, medication errors, supply shortage), regulatory guidance and compliance technologies governing the P&L procedures across jurisdictions are transforming and becoming increasingly sophisticated.

This masterclass offers global insights into and practical guidelines for ensuring P&L compliance throughout manufacturing, artwork, drug registration and distribution processes. Attendees will revise important global & regional regulations relating to P&L, how GMP-compliant artwork processes & technologies maximise drug supply chain integrity as well as disputes related to drug P&L quality. Case studies including OTC, Biosimilars, Combination products, APIs will also be examined in detail to offer attendees practical case studies in real-world setting.

Key Learning Outcomes & Case Studies Include

  • 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

pricing

Packages Price
Live Online LearningSGD $2876

Register Group of 10 for SGD $12,950

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate only.
For Group Registrations, email register@informa.com 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.
  • 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-Treasurer), CEO, Michor Consulting

Salma has advised numerous clients across Pharmaceutical, Medical and Food industries, including J&J, Novartis, Pfizer, Shire and many more. Her specialties are:

  • Technical leadership across 4 departments: Regulatory Affairs and Compliance; Medical and Vigilance; Change Control and Life Cycle Management; Packaging and Pharmaceutical Editing
  • Forming clinical and registration strategies for medicinal products (combination, generics)
  • Consolidation of Multi-language labelling texts for pharmaceutical products and medical devices
  • Labelling compliance for medicinal products and food supplement
  • Managing large company-wide compliance projects (CAPA, GMP, ISO, FDA etc)
  • Preparing companies in 3rd countries for EMA, MHRA and AGES inspections and managing the whole biotech registration and clinical testing in the EU
  • Post-acquisition phase-out and closedown after M&As

Live Online Learning

Stay Home. Skill Up!

The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.

To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.

Benefits of Live Online Learning

Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.

  • Classroom Experience: Progress with fellow participants as you would in an on-site class
  • Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
  • Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
  • Module-based approach to effectively manage your time and revisions
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Onboarding: Available for all attendees
  • Proven and secure training platform

 

Click here to know more >

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Earners of this badge have acquired advanced-level understanding of regulatory, technical requirements in developing & maintaining compliant artwork, packaging & labelling processes for medicinal products across pharma value chain (including OTC, biosimilars, combination and API products). They have also examined practical strategies for successful deployment of track-and-trace and serialisation programmes which maximise anti-counterfeiting, patient adherence objectives and optimising drug supply chain security

Skills:
packaging, labelling, drug supply chain, patient adherence, OTC, biosimilars, combination products, API products, regulatory affairs, market access, production control, quality assurance, supply chain, drug marketing, GMP-compliant artwork, track-and-trace, serialisation

Eligibility:
Attend and participate in the full training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

MODULE 1

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

 

MODULE 2

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

 

MODULE 3

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

 

MODULE 4

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

02 - 05 Nov 2020

4-Day Live Online
1:30 pm – 5:30 pm (SGT)

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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