FDA Law Blog: Biosimilars

JULY 17, 2024

These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).

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Clinical Pharmacology Drug Development 105

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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Putting Patients First Blog

AUGUST 15, 2024

hosted a series of workshops with patients, patient organizations, industry, and other stakeholders to develop a document known as the ‘Patient Experience Dossier’ (PED). In addition, patient experience data has also been included as part of the 21 st Century Cures Act which would assist the U.S.

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Documentation Drug Development 52

pharmaphorum

OCTOBER 7, 2020

Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects. Workshop: October 30th, 2020.

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pharmaphorum

OCTOBER 12, 2020

In addition to the agenda, there will be two pre-conference interactive workshops on: Workshop A – 08.30 – 12.30 on How to Develop Physiologically Relevant Immune Competent Models in MPS, led by Pelin Candarlioglu, Investigator – Bioengineer/Cell Biologist, GSK. Workshop B – 13.30 – 17.30 — ENDS –.

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Immunity Immunization Drug Development 52

pharmaphorum

NOVEMBER 22, 2021

The inaugural Next Generation Kinase Inhibitors Summit is the only industry-focused meeting dedicated to applying novel kinase biology to drug development and innovating existing programs to produce the next wave of kinase inhibitor drugs that are able to show efficacious and durable clinical response in oncology and beyond.

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Express Pharma

OCTOBER 19, 2024

Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D.

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Drug Development Documentation 111

pharmaphorum

SEPTEMBER 2, 2020

Enhance capital efficiency to re-invest in drug development programs. Panel Discussions, Workshops and Case studies on how the industry is tackling the Covid-19 crisis and implement social distancing in the lab. 2 On-Demand Workshops to optimize your facility design, and implement digitalization & LIMS.

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Drug Development 52

pharmaphorum

JULY 26, 2022

The 5th Annual Targeted Protein Degradation Summit returns to Boston as the most comprehensive, definitive event of the year, uniting 700+ large pharma, innovative biotech and world-renowned academics to discuss the full breadth of protein degrader drug development.

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Drug Development 52

pharmaphorum

JANUARY 27, 2022

The inaugural LNP Formulation & Process Development Summit is the industry’s first forum dedicated to bringing together drug developers within the LNP field to share the latest scientific breakthroughs on formulation and process development. Join 80+ of your peers and be part of this growing community.

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Vaccines Drug Development 52

pharmaphorum

NOVEMBER 24, 2022

In 2021, LifeArc held a workshop (PDF) to explore the opportunities and challenges of repurposing drugs, developing a toolkit with the Medical Research Council (MRC). billion after selling a portion of its royalty interest in Merck & Co’s blockbuster cancer drug Keytruda to a pension fund.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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Quality Matters

NOVEMBER 10, 2022

and other countries to help guard against potential drug shortages and medicines supply chain disruptions. Implementing such innovation will take time, however, in part because of obstacles that some drug developers and manufacturers can face when considering whether to adopt PCM.

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Drug Development 52

pharmaphorum

APRIL 29, 2021

The scientific community will gather to discuss the translational challenges hindering drug developers working on different drug delivery approaches, and explore new approaches, such as gene therapy, to identify potential clinical success. 3-day Conference | June 28-30, 2021.

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Drug Development 52

Drug Channels

FEBRUARY 6, 2023

View the full agenda here.

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Specialty Pharmacies Hospitals Drug Development 57

Express Pharma

APRIL 19, 2023

Championing formulation excellence Similar to Roquette’s other Innovation Centers, the new US facility is dedicated to furthering the field of pharma science through cross-industry collaboration, research-led product development and a drive to improve patients’ lives.

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Dosage Drug Development 52

FDA Law Blog: Biosimilars

MAY 4, 2023

For example, in March 2023, FDA issued a Framework for the Use of Digital Health Technologies in Drug and Biological Product Development , which noted that FDA would publish guidance on the use of DHTs in both traditional and decentralized clinical trials.

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Drug Development 59

Pulses

AUGUST 31, 2023

Table 2: Applications of Virtual Technology in Pharmacy Education AR VR MR XR Metaverse Virtual Laboratories √ √ 3D Anatomy and Physiology Visualization √ √ √ √ √ Drug Information and Interaction Visualizations √ √ √ Medication Administration Training √ √ √ Pharmacy Workflow and Practice Simulations √ Disease Simulation √ Medication Labeling and Packaging (..)

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Quality Matters

AUGUST 18, 2023

Though practices outlined in the guide are not official USP quality standards and are not intended to be binding or considered to be the only acceptable approach, they may be useful in developing PCM processes and facilitating adoption of PCM. Who should use the guide?

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Drug Development 52

pharmaphorum

OCTOBER 11, 2022

If you look at companies like Amazon and Google, the big tech companies, whenever they’ve gone into drug development on that side, they’ve found it incredibly hard. On the second day, he will be running a workshop on patient centricity. It’s very risky; it’s very hard to do.

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Communication Diabetes Drug Development 98

Pharma Marketing Network

NOVEMBER 15, 2024

From discussions on branded drug developments to sessions hosted by major players like Pfizer and Novartis , there’s always something to learn. Look for local meetups, industry workshops, and smaller conferences that offer discounted early-bird rates. Actionable Insight: Post relevant questions or comments during these events.

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Drug Development 40

Viseven

JULY 25, 2024

We brought our A-game with a workshop led by our Head of Content Strategy and Enablement, Prasant Vijayakumar. Through a diverse array of panels, keynotes, and interactive workshops, participants immersed themselves in the forefront of technological advancement. “Unveiling the Future: The Quest for Complete Content Automation.”

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Communication Drug Development 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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Documentation Packaging Clinical Pharmacology Drug Development 59

Putting Patients First Blog

APRIL 30, 2024

This could include workshops, webinars, and online resources that provide insights into cultural competence in research settings. To support these enhancements, the NHC recommends the development of a comprehensive training module for IRB members and ethics committees that covers the nuances of evaluating informed consent materials.

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Viseven

AUGUST 7, 2024

This will give you access to industry expert-led courses, scientific workshops, and mentoring opportunities. In these courses, new employees learn about various types of regulatory documents, in-house templates, style guides, the drug development process, and more. Also, let’s not forget about virtual communication.

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Putting Patients First Blog

FEBRUARY 6, 2024

Rutta Chief Executive Officer 1 National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation. Innovation in drug research and development for prevalent chronic diseases: proceedings of a workshop.

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Communication Documentation Drug Development 40

pharmaphorum

MARCH 14, 2022

Drug development. Exploratory development. Interactive Workshop on Friday 6 May 2022 on… Molecular and Cellular Pathophysiology of Pain Resolution. Workshop Leaders: Luda Diatchenko, Canada Research Chair in Human Pain Genetics, Department of Anesthesia, Faculty of Medicine, McGill University.

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Compounding Drug Development 52

Quality Matters

MAY 21, 2024

However, countries around the globe are at various stages of development for their regulatory policies. It can be overwhelming to know where to start to address nitrosamine impurities in drug products. Before the COVID pandemic, industry issues like this were often dealt with in a silo.

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Pharmaceutical Manufacturing Compounding Drug Development 52

Express Pharma

DECEMBER 12, 2024

The workshop, coordinated by Dr Jitendra Kumar, MD, BIRAC and Alokparna Sengupta, MD, HSI/India, brought together academia, industry, government, and regulatory bodies to strategise the driving innovation factors in the sector and attract investments.

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Drug Development 94