Express Pharma

APRIL 2, 2024

In this video: Prashant Deshpande, Head – Process Technology & Support, ACG World Topic: ACG Lab: Process Development and Optimisation made easy Key Takeaway: Process optimisation in pharma helps reduce manufacturing costs, increase efficiency, improve scalability, enable faster time to market, optimise resource allocation, boost product (..)

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Express Pharma

MARCH 18, 2024

Sun Pharmaceutical Industries announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi (clascoterone cream 1%). Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

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Express Pharma

SEPTEMBER 26, 2023

In this video: Girraj Tripathi, Senior General Manager and Site Quality Head, Sun Pharma Topic: Regulatory challenges and compliance Key Takeaway: The cost of poor quality and regulatory non-compliance is huge. They cause loss of time, money and reputation.

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Express Pharma

SEPTEMBER 27, 2023

Cassiopea will receive an upfront payment of $5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales. Winlevi has become the most prescribed branded topical acne drug in the US.; The EU acne market is projected to grow from $928.7 million in 2021 to $1,297.0 million in 2028.

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Express Pharma

SEPTEMBER 26, 2023

In this video: Keynote Address by Dr Rajesh Gupta, All India Head-Pharma, Laghu Udyog Bharati, President – Himachal Drugs Manufacturers Association Topic: The regulatory perspective Key Takeaway: India Pharma Inc needs to document our data better, balance quality and cost, as well as improve continously to enable regulatory compliance and maintain (..)

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Documentation 52

Express Pharma

JUNE 29, 2023

In this video: Ravi Chander Katta, Site Quality Lead (SQOL) – Vizag, Pfizer Global Supply – Global Sterile Injectables Topic: Elevating Pharma Performance: Regulatory Compliance And Quality Assurance Key Takeaway: Use of real time data analytics, AI will drive process excellence in pharma and elevate regulatory compliance The post Ravi Chander Katta, (..)

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FDA Law Blog: Biosimilars

APRIL 30, 2024

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. The draft guidance echoes the existing guidance in that the pre-submission should be limited to 3-4 topics; however, the draft guidance goes further and recommends a limit of 7-10 questions across those topics.

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Communication 64

Express Pharma

MAY 6, 2024

Topics of sessions delved into the future of pharmaceutical manufacturing, focusing on Industry 4.0 Presentations covered diverse topics: Erika Diago Rufino, Director Regulatory Affairs of Johnson and Johnson Innovative Medicine, talked about e-labeling in Brazil. and Produlab Pharma. advancements like MES and robotics.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 81

Safe Biologics

MAY 5, 2023

During the webinar, academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US shared their experience and knowledge.

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Biosimilars 100

Safe Biologics

MAY 5, 2023

During the webinar, academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US shared their experience and knowledge.

Biosimilars 100

Biosimilars 100

Express Pharma

SEPTEMBER 20, 2023

In this video: Manickam Perumal, Site Quality Head, Lupin, Pithampur Topic: Regulatory compliance in the digital age Key Takeaway: Digitalisation in pharma betters operational efficiency, reduces risk of human errors, improves quality and ensures transparency.

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PharmExec

DECEMBER 20, 2023

This podcast addresses critical topics such as cybersecurity, regulatory compliance and fiscal strategy for pharmaceutical labs and offers valuable insights for professionals at the crossroads of technology, finance, and pharmaceutical regulations.

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PharmExec

DECEMBER 20, 2023

This podcast addresses critical topics such as cybersecurity, regulatory compliance and fiscal strategy for pharmaceutical labs and offers valuable insights for professionals at the crossroads of technology, finance, and pharmaceutical regulations.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

Express Pharma

JUNE 29, 2023

In this video: K Raja Bhanu, Deputy Director & Joint Director (FAC), Drugs Control Administration, Visakhapatnam, Region of Andhra Pradesh Topic: Keynote Address: The Regulatory Perspective Key Takeaway: We need a cultural shift and a growth mind set to evolve continuously, and hone our strengths to become future ready The post K Raja Bhanu, Deputy (..)

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Express Pharma

SEPTEMBER 12, 2023

Dr Damodharan Muniyandi from Sai Lifesciences delivered the keynote address, shedding light on the key challenges of cleaning validation while emphasising the regulatory perspective.

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PharmaState Academy

AUGUST 22, 2023

The winner will be announced on 27th Aug (Sunday) in the Upcoming Career Counseling Session on the Topic: "Regulatory Affairs". Regulatory Affairs Quiz Competition Learn more about how effective regulatory affairs management is transforming the pharmaceutical industry’s compliance landscape and innovation journey.

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Pharmaceutical Business Review

NOVEMBER 20, 2023

Adhere study evaluated lebrikizumab along with topical corticosteroids (TCS) to treat adult and adolescent patients with this condition. Almirall anticipates regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis across more European countries, including Switzerland and the UK.

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European Pharmaceutical Review

OCTOBER 13, 2022

The first focus will be to improve how work related to COVID-19 is handled: interactions with regulators, prioritising topics, managing medicines with no marketing authorisation, planning for HTAs and economic modelling methods. The bodies will work collectively on scientific and methodological topics to address these difficulties.

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Communication 87

European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

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Vaccines 96

RX Note

FEBRUARY 11, 2024

Topical teething gels*. UpToDate does not recommend OTC (including homeopathic remedies) or prescription-strength topical analgesics (e.g., Management The appropriate management of teething is to relieve local discomfort. Chewing on a chilled [not frozen] teething ring. The use of analgesics ( paracetamol suspension) for pain.

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Adverse Reactions Labelling Community Pharmacies 52

PharmaShots

JUNE 23, 2023

Shots: Cassiopea will receive an up front & is also eligible to receive regulatory and sales milestones along with royalties on net sales Hyundai Pharm to get an exclusive right to register and commercialize Winlevi in the Republic of Korea while Cosmo will be the exclusive supplier of the product.

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PharmaState Academy

MAY 2, 2023

This year’s conference promises to be a stimulating experience with an array of topics covering the latest discoveries, developments, and innovations in the industry. The conference program has been designed to cover a wide range of topics such as drug design and discovery, pharmacology, clinical trials, regulatory affairs, and more.

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Express Pharma

DECEMBER 7, 2023

Speaking on FDCA’s efforts, as a regulatory agency, to help build and sustain and healthy and thriving pharma sector in the state, Dr Koshia detailed how technology was leveraged to implement e-governance, and various advanced tools of enforcement were utilised to enable quality enforcement in the state by the regulatory officials.

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Generic Medicine Documentation 104

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The speaker faculty of top FDA regulatory authorities will share critical insights on foreign and domestics inspections, digital health, DOJ’s compliance guidelines, and data privacy, among many other topics. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

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Communication 59

Pharma Leaders

MAY 8, 2023

In August 2022 the company submitted concizumab, an anti-tissue factor pathway inhibitor antibody, for regulatory approval for treatment of hemophilia A and B with inhibitors. Related Topics Novo Nordisk also said it is evaluating the content of the CRL and will work with the FDA to provide the requested data.

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Express Pharma

JULY 29, 2023

In this video: WonHyun (James) Hwang, Head of Application, Asia and Middle East of Africa Biopharma, Avantor Performance Materials Korea Topic: Impact on final formulation by Bakerbond® Chromatography Resin Key Highlights: 1) Our BAKERBOND chromatography data range and ligand information are provided in regulatory support files along with methods to (..)

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European Pharmaceutical Review

NOVEMBER 17, 2023

Lebrikizumab represents a “significant step forward” in patients with moderate-to-severe atopic dermatitis not controlled with topical therapy due to its selective mechanism of action, proven short and long-term efficacy and safety and a monthly maintenance dosing for all patients. EC approval was based on three pivotal Phase III studies.

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Hospitals 86

FDA Law Blog: Biosimilars

MARCH 15, 2023

Topics will include FDA and USDA regulatory compliance and enforcement, inspections, recalls, food safety technology, and emerging and growing product categories such as cell-cultured meat and Cannabis ingredient-infused products.

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Pharma Mirror

SEPTEMBER 4, 2020

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry.

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PharmaTech

FEBRUARY 23, 2023

We cover topics including regulatory compliance, manufacturer flexibility & supply chain risk and debate the supplier vs partner relationship and the importance of collaboration as we face a challenging future.

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Pharma Leaders

JUNE 8, 2023

Under PDUFA VII, the agency agreed to create the program by December 2022 and then to report aggregate data on an annual basis starting June 30, 2024, including data sources, study designs and the types of regulatory requests. Related Topics

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Drug Development 40

Pharmaceutical Technology

MAY 24, 2023

Streamlining the regulatory process, the AMP BGTC will also facilitate cost-efficient vector production to increase access for patients with rare and ultra-rare genetic diseases. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

DECEMBER 5, 2022

According to the deal, Incyte is entitled to receive an upfront payment from CMS, which will also make further potential payments on meeting development, regulatory and commercial milestones. Ruxolitinib cream is the first topical inhibitor of JAK to obtain approval in the US.

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Express Pharma

OCTOBER 5, 2023

The sessions covered various topics including quality culture, data integrity within the context of quality, capacity building, next-generation operations, and India’s journey towards quality leadership. Good manufacturing practices ensure regulatory compliance and foster stakeholder relationships.

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Express Pharma

MAY 22, 2023

Carbopol is a versatile polymer having applications as a viscosity modifying agent, drug release retardant, and mucoadhesive agent in oral as well as topical drug delivery. However, two eminent speakers from Lubrizol shared their knowledge and vast experience on various aspects of carbopol polymers during the seminar.

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Dosage 94

Pharmaceutical Technology

JUNE 9, 2023

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

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