Product Launch Planning Workshop
Join us at our Product Launch Planning Workshop in Cambridge, MA. May 10, 2022. Orphan Drug Consulting is delighted to invite you to attend our complimentary workshop titled Product Launch Planning – Phase Appropriate Strategies from the Clinic through to Commercial Bringing a pharmaceutical product to the market is no easy task. There are […]
Rare Disease Day 2022
What is Rare Disease Day? Rare Disease Day is a patient-led globally coordinated movement on rare diseases, working towards equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease. Rare Disease Day was established by EURORDIS and 65+ national alliance patient organization partners in 2008. Rare Disease […]
Choosing the Right 3PL Service Provider in Europe
Introduction Extensive growth in the pharmaceutical industry over the last number of years has resulted in an increased demand for third-party logistics (3PL) services as companies began to outsource and adopt more virtual operations. Outsourcing to a third-party logistics provider can often save companies money and time by allowing them to avoid the ongoing investments […]
EU Regulatory Flexibility During COVID-19 Pandemic
In these uncertain times it can be challenging to comply with regulatory requirements while maintaining supply demands, but there has been advice published by the authorities to help. This guidance has outlined regulatory flexibility that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of […]
EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’
On 20th March 2020 the EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’ was published as a draft. In addition to the guidance outlined in the main chapters and annexes, it was a thought that there was a need to publish a specific guideline on importation of medicinal products under a dedicated annex of […]
The Impact of Coronavirus (SARS-CoV-2) and COVID-19 on Global Pharmaceutical Supply Chains with Focus on the Indian and Chinese Markets
On 31st of December 2019, a cluster of pneumonia cases with unknown aetiology were reported in Wuhan, China. At the time, healthcare professionals could not identify the causative agent for these seemingly related incidents but on the 7th of January the Chinese authorities confirmed a novel coronavirus (nCoV) was responsible for the disease. This virus […]
Rare Diseases Day 2020: The Importance of Orphan Drugs in Combating Rare Diseases
An Overview of Rare Diseases: On February 29th, 2020 the world will observe Rare Diseases Day coordinated by the European Organisation for Rare Diseases (EURODIS). Now in its 13th year, this special day aims to spread awareness of rare diseases and the patients whose lives are impacted by them. But what exactly is a rare […]
Advanced Therapy Medicinal Products (ATMPs)
With the rise of new therapeutic modalities, regulators have had to adapt to the changing environment and one of these adaptions is through the introduction of Advanced Therapy Medicinal Products (ATMPs). This article highlights some of the key considerations of working with ATMPs.
Brexit
The United Kingdom (UK) voted in a referendum on June 23rd, 2016 to leave the European Union (EU), by 52% to 48%, leaving the Single Market and the Customs Union. While the referendum was not legally binding, the UK government at the time promised to honour the result. The UK has population of over 66 […]