ABPI Code feedback

It has long been communicated to the UK pharmaceutical industry that the Prescription Medicines Code of Practice Authority (PMCPA) welcomes all input and feedback on the ABPI Code of Practice. But what does this actually mean, what does the PMCPA do with such feedback, and what motivates feedback or prevents it from being given?

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The use of LinkedIn and the ABPI Code of Practice

The Prescription Medicines Code of Practice Authority (PMCPA) has received at least nine complaints to-date about the use of LinkedIn, indicating that its use, which is not specifically addressed in the ABPI Code of Practice (Code), may benefit from guidance on how to adhere to existing principles whilst also respecting the purpose of LinkedIn. This should help ensure the LinkedIn accounts and activities of pharmaceutical companies and pharmaceutical/agency employees, comply with the Code.

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Agencies and the ABPI code of practice

Rina Newton shares her top tips for ensuring agencies comply with the ABPI Code of Practice. Agencies are engaged by pharmaceutical companies because the expertise they offer may not be available in-house or because there is insufficient resource or time for in-house creation and development.

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How does the ABPI Code apply to congresses?

How does the ABPI Code apply to congresses? Mitigating the risks of breaching the Code. The ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements.

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Together Beyond COVID-19 - A Look to the Future

International Pharmaceutical Industry: Marta Vila Ramos discusses the impact of COVID-19 on the industry and what we can expect in the future.

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Why you never really validate your analytical method unless you use the total error approach (part II: Producer and Consumer risks)

This is a second article in series of articles on the total error approach within the context of analytical method validation. If you missed the first article, I encourage you to read it to get familiar with the total error concept and what we are going to discuss below: https://www.linkedin.com/pulse/why-you-never-really-validate-your-analytical-method-use-de-marchin

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The Outlook for a Year of Change

Over the past 12 months, the bio/pharma industry has faced unprecedented challenges head on, working in unique and remote ways, and forming new and unlikely partnerships to help in the fight against the COVID-19 pandemic. Although a hugely impactful aspect of 2020, COVID-19 has not been the only trial of the year; bio/pharma companies have also had to keep a watchful eye on Brexit—the departure of the United Kingdom from the European Union—which is expected to cause broad-level disruptions to companies throughout the region.

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Why you never really validate your analytical method unless you use the total error approach (part I: concept)

Consistent and efficient use of any analytical procedure requires the knowledge of its reliability prior to its use. It is therefore necessary for each laboratory to validate their analytical methods. Validation is not only required by regulatory authorities [ICH, FDA, GxP] or in order to access accreditation [ISO 17025] but is also the essential step prior to the routine use of the method. The role of analytical method validation is to provide confidence in laboratory generated results that will later be used to make critical decisions.

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New SAS solutions for Population PK Model

Population pharmacokinetic (PK) models describe the drug concentration-time course in body fluids resulting from administration of a certain drug dose. Compartment models are typically used to conceptualize the mechanisms that take place in the interaction between an organism and a drug product.

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Bayesian Power, Assurance and Probability of Success: Reproducibility Issues

In this current document, we will try to analyze the effects that a misunderstanding of these concepts may lead to and more specifically the effects on reproducibility.

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Bayesian Power, Assurance and Probability of success: A quick who’s who

Bayesian power and Assurance allows accounting for the uncertainty on the parameters. These metrics give estimates closer to a probability of success that the trial will indeed be a success. Uncertainty must be accounted for in order to ensure that the appropriate sample size is selected in order to maximize the success of the clinical trial. Read the full article here

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Proposal for a Single Arm Clinical Study in Rare Disease using Bayesian Statistics

This short article aims to briefly introduce a methodology to address the challenge of rare clinical trials relying on Bayesian statistical methods, and the use of natural history data to determine the control group and inform the analytical model. You can read the full article here

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Non-clinical safety evaluation of vaccines accelerating clinical development

International Pharmaceutical Industry: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines

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Non-clinical safety evaluation of vaccines accelerating clinical development

Chemistry Today: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines

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Successful marketing of medicinal cannabis

Teknoscienze – Chemistry Today: Barbara Siebertz and Ute Hegener look at the national legal requirements of some European countries on medicinal cannabis, while highlighting the differences within the EU.

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Supporting M&As in the pharmaceutical/biopharmaceutical industry

Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.

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Successful marketing of medicinal cannabis part II

Nutraceutical Business Review: Barbara Siebertz and Ute Hegener discuss the current legal and marketing situation in Europe

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Successful marketing of medicinal cannabis part I

Nutraceutical Business Review: Barbara Siebertz and Ute Hegener discuss the current legal and marketing situation in Europe

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Non-clinical safety evaluation of vaccines part II

Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines

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Non-clinical safety evaluation of vaccines part I

Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines

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Improving the chances of EU approval

International Clinical Trials: Improving the chances of EU approval – Lisa Pascoe and Lucy Gluyas discuss the steps required to ensure a successful Clinical Trial Application (CTA)

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Successful marketing of medicinal cannabis

International Pharmaceutical Industry: Barbara Siebertz and Ute Hegener look at the national legal requirements of some European countries on medicinal cannabis, while highlighting the differences within the EU.

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Can a robust QMS help you achieve customer satisfaction?

PharmaLex.pert Limaris Alvarado discusses the part quality management systems (QMS) play in ensuring companies continually enhance customers’ experience and satisfaction?

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Product Launch

PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.

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Together Beyond COVID-19

PharmaLex.perts Jürgen Hönig and Lisa Pascoe discuss the challenges COVID-19 has placed on the pharma industry – from R&D to clinical trials and manufacturing to drug safety – and how companies like PharmaLex are working together with the industry to ensure regulatory compliance.

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Learning Lessons from Nitrosamine Impurities

PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

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Quality Investigations & CAPAs "Elementary, my dear Watson"​

PharmaLex.pert Gerado Gomez discusses the importance of Quality and Complaint Investigations and CAPA Management

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Drug Development Decisions

Zeb Younes & Zaklina Buljovcic will give you insightful information about new approaches to Drug Development. This article is taken from the European Biopharmaceutical Review October 2019, pages 58-64. © Samedan Ltd.

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The FDA is shifting focus to both ends of the NPD spectrum

PharmaLex’s Andrew S. Verderame looks at how the FDA are introducing new measures to process and approve more complex novel and generic therapies  – p52-53

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EPR - the regulatory intelligence the platform deserves

PharmaLex’s Jürgen Hönig and Rob Williams discuss the key elements of developing a successful knowledge-management plan – p12

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Latin America Leans Towards Greater Regulatory Harmonization

PharmaLex’s Diego Zavala and Fatima Monterio discuss how regulatory harmonization is gathering pace in Latin America, spelling good news for pharmaceutical companies.. *subscription required*

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Spot the Difference

Torben Thers Nørgaard looks at Scandinavia and how the countries have very different rules and regulations when it comes to doing business: http://www.samedanltd.com/magazine/12.

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In the case of a ‘no deal’ Brexit: the supply of medicines

Jonathan Trethowan looks at how we can safeguard our supply of medicines in the case of ‘no deal’ Brexit

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The Evolving Influence of the FDA on Pharma

Andrew S. Verderame, RAC MBA shares his thoughts on the evolving influence of the FDA on pharma.

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Regulatory intelligence – from knowledge to added value

Dr. Jürgen Hönig and Rob Williams look into the benefits of having the right information.

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TOPRA // Regulatory Rapporteur Vol 15, No 10, October 2018

PharmaLex’s Tilo Netzer, Timm Pauli and Jonathan Trethowan provide their views on the number of opportunities for use of AI in clinical development and during lifecycle management of healthcare products in the latest issue of TOPRA’s Regulatory Rapporteur.

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Improving Availability of Medicines in the EU

PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses the EMA’s Heads of Medicines Agency (HMA) two-year work program on improving medicines supply in the EU.

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EMA simplifies the process for internal transfer of MAs

PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.

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Brexit Uncertainty - impact on medicines supply

PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan looks at what impact Brexit might have on medicines supply across the EU

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AI in drug development|Pharmacovigilance

PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to pharmacovigilance

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AI in drug development: Regulatory Affairs - Part 1: Regulatory Affairs

PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to regulatory affairs

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The 5 things you want to know about Artificial Intelligence

PharmaLex CEO, Tilo Netzer explains the five things you should know about Artificial Intelligence

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Moving From Artificial Trials To Smarter Regulatory Process

PharmaLex’s Bruno Boulanger discusses the impact big data will have on how the pharmaceutical industry gathers and delivers data in the future. *subscription required*

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Digitally Transforming Pharma’s Regulatory Processes

In the latest issue of pharmaphorum’s deepdive: Future Pharma 2018, Rob Williams and Timm Pauli discuss Digitally Transforming Pharma’s Regulatory Processes

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