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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 Will Benefit
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
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 Training
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Catering to meet all your learning needs:
- Get high quality practical training from our expert instructors
- From Face To Face, Online and Blended Learning, get a superior solution for your learning needs
- Learn live online in an interactive environment
- Invest in yourself. Invest in your team.
Register today for our Live Online Training courses and find out how they can help you transform the way you work. Contact one of our training consultants on [email protected] to find out more.
Testimonials
“The programme includes good overview information on pharma strategies across the ASEAN region. I enjoyed the global drug trends discussion”
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”
Regional Financial Controller, IPSEN Pharma Singapore
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
On-site & in-house training
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