Meetings/Workshops on Regulation in Medicine and Pharmacology in the United Kingdom

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1
Biosimilars & Biobetters 2017
27 Sep 2017 - 28 Sep 2017 • London, United Kingdom
Abstract:
SMi Group are thrilled to present the 2017 8th annual conference on Biosimilars & Biobetters taking place on 27th & 28th September in Central London, UK. As the patents for several innovator biologics expire, biopharmaceutical companies are taking the opportunity to develop more affordable forms creating a rapidly booming biosimilars market. However, as the field of biosimilars evolves, challenges in immunogenicity studies, securing market share, exclusivity and regulations still persist. Created with a top panel of industry thought leaders, Biosimilars & Biobetters 2017 will tackle these challenges head on by honing in on current market trends, emerging opportunities and global developments. Join us this autumn to arm yourself with the key requirements and tools for successful market entry through strategic direction on commercialisation; insight into potential therapeutic areas; and critical updates on interchangeability guidelines and patient litigation.

A must attend for principle scientists and regulatory experts involved in biotechnology, market access and compliance, this years event will feature expert insight from Boehringer Ingelheim, Celltrion Healthcare, QuintilesIMS, Merck Group, Norwegian Medicines Agency, Teva Pharmaceuticals, Biocon, Gedeon Richter, Prolong Pharmaceuticals, Lupin Europe and more!

Contact:
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics:
biosimilars, biobetters, conference, regulatory, patent, us market, generics, pricing and reimbursement, market access, commercialisation, EU, global developments, emerging markets, pharmacovigilance, protein characterisation, analytical comparability, approval, immunogenicity, pqa, product quality assessment, comparative analysis, pricing and reimbursement, p&r, litigation, , European regulation, biogenerics, IP, intellectual property, data protection, supplementary protection certificate, payer
Event listing ID:
904110
Related subject(s):
2
Edinburgh CRF: Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection
10 Oct 2017 • Edinburgh, United Kingdom
Abstract:
Statutory GCP inspections conducted by the Medicines and Healthcare products Regulatory Agency (MHRA), are an important part of the regulation of clinical trials in the UK. Anyone who sponsors, conducts or supports a clinical trial in humans involving an investigational medicinal product (CTIMP) or a medical device may find themselves face-to-face with an MHRA inspector. What an inspector will be looking for is evidence that trials have been conducted in compliance with applicable legislation and the principles of GCP. It is a daunting prospect for many, but an understanding of what to expect and how to prepare can help smooth the process and lead to a successful inspection outcome.

This half-day course will use presentations and workshops to provide an overview of the GCP inspection process from notification to closure, along with some handy hints and tips for surviving the experience relatively unscathed. It is aimed at anyone who may be involved in an MHRA GCP inspection.

Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
912933
Related subject(s):
Event website:
3
Pharmaceutical Pricing and Market Access
11 Oct 2017 - 12 Oct 2017 • London, United Kingdom
Abstract:
SMi Group presents the 23rd annual industry leading summit on Pharmaceutical Pricing & Market Access, 11 – 12 Oct 2017, London, UK. Pharmaceutical Pricing & Market Access 2017 will tackle industry challenges head on by preparing attendees to develop a successful market access strategy for the ever changing pharmaceutical and payer landscape. Join us this autumn for insight into how manufactures plan to limit further price increase; a progressive outlook into the future of pharmaceutical pricing & reimbursement (P&R); stakeholder collaboration; meaningful patient engagement opportunities; and discuss what can be done for the industry to achieve efficient reimbursement and for patients to gain access to affordable medication. Highlights will include an exclusive opening keynote from the FDA and interactive training on Real World Evidence (RWE). Featured Speakers include: Lundbeck, FDA, Shire, Sobi, Teva, Grifols, Allergan, Sanofi and more!
Contact:
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics:
Pharmaceutical Pricing & Reimbursement, market access, AMNOG, orphan drugs, biosimilars, brexit, NICE, P&R, premarket, postmarket, strategy, price, affordable, economic, payer, value proposition, disease, patient engagement, emerging market, real world data, RWE, real world evidence, medicine, drug, HTA, regulation, regulatory, orphan drugs, rare diseases, external affairs, FDA, regulatory review, translational, commercial, biopharma, international reference pricing, IRP, currency, value, stakeholder, fund, invest, budget, cost, accelerated access review, AAR, , value, value based pricing, therapeutic, health economic, positioning, commercial, viability
Event listing ID:
904175
Related subject(s):
4
COLD CHAIN — SMi's 12th annual Cold Chain Distribution Conference and Exhibition
13 Dec 2017 - 14 Dec 2017 • London, United Kingdom
Abstract:
As the global healthcare industry grows, temperature controlled logistics rapidly evolves along with it. Factors such as the ever-changing regulatory requirements, diverse array of biopharma products entering the markets, and new technology emerging daily, are causing companies to face the challenge of constantly adapting their supply chain processes and staying ahead of the curve. Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation. With huge interest from leaders in the field, we have worked closely with an expert panel of speakers to present an agenda that is shaping up to be the best Cold Chain Distribution event. This year's event will continue to lead with its unrivaled panel of experts bringing you the most insightful presentations from our confirmed Industry-leading speakers from: Exelsius, Sanofi Genzyme, World Courier, Modalis, Eli Lilly, EMBALL'ISO, GlaxoSmithKline, World Health Organization, European Association of Pharmaceutical Full Line-Wholesalers (GIRP), National Institute for Biological Standards And Control, SeerPharma (UK), Merck SpA and many more!
Contact:
Kyra Williams;     Phone: [2078276012];     Email: kwilliams@smi-online.co.uk
Topics:
GDP Guidelines, Cold Chain Distribution, Temperature Control, Supply Chain, Logistics, Temperature Monitoring, Stability Studies
Event listing ID:
918826

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Last updated: 28 June 2017