<span>LandschulzNASHsummit19.pdf</span>
April 22, 2019

LandschulzNASHsummit19.pdf

NASH Summit 2019 -- Approximately 25-30% of the global adult population have non-alcoholic fatty liver disease (NAFLD), a chronic disease characterized by the accumulation of excess fat in the liver.
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<span>PaunickaSQA19.pdf</span>
April 28, 2019

PaunickaSQA19.pdf

SQA 2019 -- Risk management must be applied throughout the entire lifecycle of drug development. Risk management provides visibility and insight to a company's greatest risks. Proactive risk mitigation strategies can be utilized to protect both your company and your client's reputation, as well as the safety of patients and product.
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<span>RiceSQA19.pdf</span>
April 28, 2019

RiceSQA19.pdf

SQA 2019 -- Risk-Based Auditing has been a significant tool for Covance quality and compliance since 2015. The assumption in this model is that higher frequency brings higher risk. While there is also risk from low frequency activities, these are deemed best for review under a study specific audit approach.
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<span>Pricing & Reimbursement in France</span>
May 10, 2019

Pricing & Reimbursement in France

France has a centralised pricing and reimbursement system, with a substantial amount of influence held by the Transparency Commission of the Haute Autorit de Sant, although public and private insurers are also involved in pricing decisions.
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<span>Pricing & Reimbursement in Spain</span>
May 10, 2019

Pricing & Reimbursement in Spain

Although there is a national pricing and reimbursement process in Spain, the 17 autonomous regions and hospitals are in control of budgets and may further restrict access, leading to disparities in coverage by region.
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<span>Pricing & Reimbursement in Germany</span>
May 10, 2019

Pricing & Reimbursement in Germany

Medicines may be priced freely for up to one year following marketing authorisation. However, a benefit dossier must still be submitted to the G-BA at launch. All medicines with marketing authorisation are reimbursed; however, the reimbursement level is based on "additional benefit" determined by the G-BA and negotiated with GKV-SpV.
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<span>Pricing & Reimbursement in England</span>
May 10, 2019

Pricing & Reimbursement in England

Reimbursement decision-making is highly centralised, being conducted by NICE according to defined cost effectiveness thresholds; however, regions and individual hospitals must manage their healthcare budgets and are therefore also key stakeholders in the reimbursement process.
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<span>GoodingBEBPA-HCP19.pdf</span>
May 15, 2019

GoodingBEBPA-HCP19.pdf

BEBPA HCP 2019 -- The most critical part of developing an ELISA for measuring Host Cell Protein (HCP) impurities in Biotherapeutics is generation of specific antibodies with appropriate recognition of the total population of HCPs potentially present in the product.
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