Regulatory Rapporteur - June 2024 | Regulatory Rapporteur

Regulatory Rapporteur – June 2024

June 2024 – Contents
The global access battle for healthcare equity
Opportunities and challenges in the Latin American pharmaceutical industry
Project Orbis – a sponsor’s perspective on the collaborative international review process
The availability of medicines post-Brexit in Malta
The UK Responsible Person Association
Over two years into the new veterinary medicines rules for the EU: a reflection on where we are now
Comparing China Drug Master Files with the EU and US
A key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation

Gene therapy restores hearing in five children
Five children with hereditary deafness have had their hearing restored in both ears through gene therapy in a clinical trial.
Critical need to address mpox strain, says WHO
The World Health Organization (WHO) has warned that it is crucial to address the spread of monkeypox as cases surge.
WHO issues global warning on fake Ozempic medication
The WHO has issued a global alert on falsified semaglutide products used to treat type 2 diabetes and obesity in some countries.

Professor Dame Sally Davies has warned that unchecked antimicrobial resistance could make the COVID-19 pandemic ’look minor’.

AstraZeneca has begun withdrawing its COVID-19 vaccine from the market because of greater availability of more up-to-date vaccines.

2024-06-26T10:05:00+01:00By Alan Booth

Vol.21 #6: In June 2024’s RegRapPod, host Alan Booth talks to Issue Editor Davina Stevenson about access to medicines

2024-05-31T00:05:00+01:00By Alan Booth and and Bengt Mattson

BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson

May 2024 – Contents
Unlocking a new paradigm of healthcare through advanced therapies
Dr Peter Marks on reflecting innovation through FDA regulation
The first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU
Near-term challenges of advanced therapy medicinal products: a maturing product class
Navigating the process complexities and challenges associated with EU-CTR transition applications
The European Association of Authorised Representatives
Medical device standards update: March 2024
RegRapPod − In Conversation with Helena Corte-Real

April 2024 – Contents
Improving outcomes with data
Data quality, governance and sharing to enable insights and decision-making
Unveiling the synergy of AI’s regulatory harmony in shaping the future of biopharmaceutical progress
Device submissions for combination products: a data-driven perspective
Navigating the future of medicinal product data exchange: understanding XEVMPD
Choosing the right registration pathway for the China drug master file: an essential analysis of options
Managing risks: successful clinical development in asthma
RegRapPod − April 2024

January 2024 – Contents
The increasing complexity of biological medicinal products
Navigating early drug development investment: a detailed guide to due diligence
A weight of evidence approach for the non-clinical evaluation of complex biologicals
Innovating and harmonising access and requirements amid the global regulatory challenges of biologics
Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
The changing face of oncology development – is cancer still ‘different’? A US perspective
Artificial intelligence in drug discovery

October 2023 – Contents
Veterinary medicines: the challenges of new regulation
Transition to the new QRD template for veterinary medicines: challenges and opportunities
Autogenous vaccines under Regulation (EU) 2019/6
Prequalification of veterinary vaccines and medicines
EMA activities related to antiparasitic veterinary medicinal products
Optimal materials selection in medical device development – a proactive biocompatibility approach

March 2024 – Contents
Diverse and dynamic regulation in the Asia Pacific region
Navigating the regulatory terrain down under: trends in Australia for 2024
Regulatory imperatives in chemistry, manufacturing, and control for biosimilars a comprehensive analysis
Can the Japanese phase I study be waived?
Overview of digital transformation in healthcare and initiatives in Japan
Clinical trial design – keeping up with innovation
New data protection for maximum residue limits

September 2023 – Contents
The worldwide web of regulation
Q&A:
Navigating the
pharmaceutical supply chain
Navigating the global supply of starting materials for cell-based therapies
Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Biosimilars CMC development considerations from the sponsor perspective
Warning letters for direct-to-consumer advertising: a five-year retrospective analysis