Vaping Industry Forum 2018 Vaping Industry Forum 2018
Vaping Industry Forum 2018 Tomorrow’s world: Next generation vaping innovations to watch out for
Headline Sponsor Vaping Industry Forum 2018 Tomorrow’s world: Next generation vaping innovations to watch out for Clive Millington Chief Executive, AYR
Slide #3, part c
And we at AYR are at the forefront of that revolution.
Smokers told us …
Smokers told us …
Smokers told us …
Slide 12 Waiting for Keeley
We’re looking forward to working with you
Vaping Industry Forum 2018
Headline Sponsor Vaping Industry Forum 2018 Tomorrow’s world: Next generation vaping innovations to watch out for Danny Sohota Managing Director, Real Trading Ltd
Vaping Industry Forum 2018 Real Trading – Who are we?
Vape Station Reinventing Vape Sales in Retail Vaping Industry Forum 2018
Vaping Industry Forum 2018 Vaping Industry Forum 2018
Headline Sponsor Vaping Industry Forum 2018 Tomorrow’s world: Next generation vaping innovations to watch out for John Dunne Managing Director, E-Liquid Brands
Vaping Industry Forum 2018
Vaping Industry Forum 2018 How do we encourage the millions of smokers who want to quit to choose vaping?
Vaping Industry Forum 2018 How do we get the different sectors of the industry to work together?
Vaping Industry Forum 2018
Vaping Industry Forum 2018 Let the Q&A session begin...
Vaping Industry Forum 2018 Vaping Industry Forum 2018
Vaping Industry Forum 2018 Panel Debate: The role of the tobacco and pharmaceutical industries in the future of vaping Chair: Gareth Johnson MP Parliamentary Private Secretary to the Secretary of State for Exiting the European Union Duncan Cunningham Dr Ian Jones Corporate & Legal Affairs UK & Ireland, Vice President of Reduced-Risk Imperial Brands Products, JTI Germana Barba Ben Wilson Vice President Regulatory Strategy & Managing Director, BSMW Ltd Engagement at Philip Morris International John Dunne Henrik Brostrom Managing Director, E-Liquid Brands Head of External Engagement – Next Generation Products - British American Tobacco
Headline Sponsor Vaping Industry Forum 2018 Taking global leadership on standards
Headline Sponsor Vaping Industry Forum 2018 Taking global leadership on standards Craig Copland E-Cigarette Unit Manager, MHRA
MHRA Update UKVIA Forum 2018 Craig Copland
MHRA responsibilities under the TPD implemented by the TRPR 2016 • Operate UK notification system via EU-CEG • Process and publish list of notified products • Operate adverse reactions scheme • Carry out vigilance tasks upon receiving reports of non compliant products in use 53
UK Notified products (31/3/18) Active – 47642 • Incomplete submissions • Current processing • Informed of intention to withdraw • Incorrect notification of intention to market in the UK Inactive - 8092 • Withdrawn by producer 54
UK Published products (31/3/18) • Total Products - 34937 • Devices - 3033 • Liquid/Refill containers - 31904 55
Vigilance • Notifications • Yellow Card • Updated portal function • Intelligence • Partnership working 56
Notifications • Missing toxicology reports • Missing Emissions reports • Six declarations often incorrectly completed • Submitted sub brand information has caused issues at retail • Please be sure to have notification check for completeness it will cause delay to your publications 57
Yellow Card 40 E-cigarette adverse reaction reports 58
Yellow Card – findings 31 (77.5%) were reported by members of the public 9 (22.5%) were reported from healthcare professionals 109 symptoms recorded across the 40 reports 59
Yellow Card – findings Graph 1 - Number of reactions associated with e-cigarettes, reported via the Yellow Card Scheme, broken down by MedDRA System Organ Class VASCULAR DISORDERS PSYCHIATRIC DISORDERS PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS INVESTIGATIONS EYE DISORDERS IMMUNE SYSTEM DISORDERS PRODUCT ISSUES INJURY, POISONING AND PROCEDURAL COMPLICATIONS CARDIAC DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS NERVOUS SYSTEM DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GASTROINTESTINAL DISORDERS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 0 5 10 15 20 25 30 Number of reactions 60
Updates to EU-CEG On-going updates to portal functionality are making it easier to review notifications for compliance of: • Ingredients • Tank capacity • Refill container size and concentration 61
Intelligence • Intelligence reports are being provided by industry • A wider Industry commitment to higher standards and vigilance • A desire to see a level playing field • Support for enforcement of the regulations 62
Funded partnership working • DHSC funded retail compliance project • 90 MHRA compliance interventions as a result of Trading Standards referrals. • Report from CTSI/DHSC due later this year 63
Funded partnership working • MHRA funded product testing with CTSI • Testing of products from the online marketplace for TRPR compliance • Report from CTSI due later this year 64
Partnership working • Continue to work with industry via trade bodies to improve compliance and best practice • Provide feedback and ongoing advice with regular news letters • Continue to provide support for local authority enforcement • Promote closer working relationships between industry and Trading Standards 65
Partnership working • EU Joint Action Tobacco Control group and EU Expert Panel • Department of Health • Public Health England 66
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Headline Sponsor Vaping Industry Forum 2018 Taking global leadership on standards Dr Sudhanshu Patwardhan Senior International Engagement Manager, BAT
Vaping Industry Forum 2018 Outline • What are standards? • Why do we need them? • Vapour products: From BSI to international standards
What are standards? Vaping Industry Forum 2018 “Documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose” ISO The standard simply provides a shorthand way of claiming that certain specifications are met, while encouraging manufacturers to adhere to a common method for such a specification.
Standards vs. Regulations Vaping Industry Forum 2018 Standards Regulations However, standards can be incorporated into or help implementation of regulations Mandated Industry led
Rationale for E-cig standards development Vaping Industry Forum 2018 Key Drivers 1. Need to assure regulators and consumers alike on the quality and safety of e-cigs, amidst growing concerns due to alarmist media reporting Vs . 2. Ensuring that a uniform harmonised approach to product quality and safety is followed globally 3. Create standards that underpin regulations (in EU) and provide a template for regulations (outside the EU)
Industry product assessment builds consumer Vaping Industry Forum 2018 confidence in product quality and safety PRODUCT PERFORMANCE VAPOR EMISSION TESTING E-LIQUID SAFETY SAFEST INGREDIENTS DEVICE SAFETY RIGOROUS TESTING QUALITY MATERIALS HIGHEST STANDARDS THOROUGH VAPOR ANALYSIS Stewardship stretches from DEVICE CERTIFICATION ingredient selection to vapour *Stewardship of *St of e-ci cigar arette fla flavours, s, S. Costigan and C. Meredith, Regul Toxicol Pharmacol . 72 72: : 361 – 369, 2015
The BSI Publicly Available Specification is the Vaping Industry Forum 2018 closest to a ‘standard’ for e - cigs… AREAS EXAMPLES IN BSI PAS Process and quality control traceability in supply chain Purity of e-liquid ingredients in manufacture pharma grade nicotine Contaminants arising from device materials shelf life studies and potential emissions from device operation Electrical safety Complying with existing directives Metals and carbonyls in emissions toxicological risk assessment
Vaping Industry Forum 2018 More is needed at the Global level • What will the new standards look like? • When can we expect them? • What will they provide?
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