ISPE

NOVEMBER 3, 2022

2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. Thu, 11/03/2022 - 13:48. 2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. 3 November 2022. 2022 ISPE Annual Meeting & Expo. Trudy Patterson. iSpeak Blog. Susan Sandler.

Communication 98

Communication FDA Documentation Vaccines 98

pharmaphorum

JANUARY 28, 2022

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

Vaccines 64

Vaccines Documentation 64

European Pharmaceutical Review

NOVEMBER 9, 2022

Within recent years this situation has been further exacerbated by the COVID-19 pandemic: both directly, through viral vaccine manufacture; and indirectly, through instability in global supply chains. Those available commercially include adenoviral-based vaccines by AstraZeneca and Johnson & Johnson. 2021 [Cited 16 September 2022].

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Vaccines Documentation Communication Hospitals 115

European Pharmaceutical Review

JUNE 27, 2022

A guidance document has been released to support these activities. The Kigali Summit on Malaria and NTDs , hosted by His Excellency (HE) Paul Kagame, President of the Republic of Rwanda, on Thursday 23 June 2022, gathered world leaders to commit to ending these devastating diseases by the end of 2030. — GSK (@GSK) June 23, 2022.

Vaccines 110

Vaccines Communication Documentation Compounding 110

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105

Packaging Vaccines Documentation FDA 105

European Pharmaceutical Review

JANUARY 13, 2023

Commission (EPC) adopted the revised general monographs 2034 and 2619 , at its 174th session in November 2022 , which now includes a paragraph explaining the Ph. European Pharmacopoeia Commission’s November 2022 session highlights: Approval of the Ph. Priorities for 2022-2025. The European Pharmacopoeia (Ph. and non-Ph.

Documentation 105

Documentation Vaccines 105

pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Chair for 2022: Gretchen Vandal, Sr. Featured 2022 Speakers Include: Joyce Zhao, Associate Director, Combination Product, Takeda. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion.

Packaging 52

Packaging FDA Documentation Vaccines 52

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 06:48. 27 October 2022. It is a great honour and pleasure for me as the 2022-2023 ISPE Board Past Chair and Chair of the 2023 ISPE Aseptic Conference Program Committee to give you a first glimpse at the program and of the information and knowledge that will be shared at the conference. Trudy Patterson.

Dosage 98

Dosage Vaccines FDA Documentation 98

pharmaphorum

NOVEMBER 16, 2022

The health technology assessment (HTA) agency has turned down five other COVID-19 therapies, notably AstraZeneca’s Evusheld (tixagevimab plus cilgavimab) – which patient organisations in the UK have been clamouring for access to, as it is an alternative to vaccinations for some vulnerable patient groups. The #cev struggle is real.

Vaccines 105

Vaccines Documentation 105

pharmaphorum

JULY 14, 2022

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

Documentation 52

Documentation Vaccines 52

pharmaphorum

APRIL 7, 2022

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). FDA gives first thinking on updating vaccines.

Vaccines 59

Vaccines Immunization FDA Documentation 59

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.

Vaccines 64

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 64

pharmaphorum

JANUARY 9, 2023

1 Kenya, for example, entered the pandemic with no human vaccines manufacturing facility and established the BioVax institute for local vaccine manufacture with a major plant investment starting in 2023. Regulatory divergence became apparent in 2022 and could increase in 2023.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

Pharmaceutical Technology

NOVEMBER 15, 2022

Within Pfizer’s Covid-19 pipeline, Pfizer and BioNtech’s vaccine Comirnaty is also being used to fight the pandemic. While bivalent formulations of Comirnaty and Moderna’s Spikevax vaccine have both been authorised for use as boosters in the UK and US, their uptake has remained slow. Paxlovid rebound study.

Vaccines 64

Vaccines Documentation FDA 64

pharmaphorum

JANUARY 13, 2023

Sanofi Ventures invests in innovators working in areas including immunology and inflammation, rare diseases, oncology, cell and gene therapy, vaccines, and digital health and data science. The team partners across all stages of the private company lifecycle, from Seed to Series B and beyond.

Documentation 52

Documentation Vaccines 52

Digital Pharmacist

NOVEMBER 21, 2022

On October 7 th , 2022 the U.S. a) Pandemic Factors: Health plans had previously been allowed to apply carryover quality criteria from 2021 and 2022. Road Towards Approval. However, in 2023, health plans should improve member engagement by scheduling a visit for preventative care or completing a missed screening.

Communication 98

Communication Documentation Immunization Vaccines 98

ISPE

AUGUST 30, 2023

to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. In a collaborative work environment, they will evaluate facility documentation and draw conclusions to be shared with the workshop team and other participants.

Documentation 98

Documentation Vaccines 98

pharmaphorum

SEPTEMBER 14, 2022

With countless media stories regarding COVID-19 published over a period of several years, it was obvious that people around the globe were tuned in to every step of the fight against the pandemic, eagerly learning about everything from symptoms to vaccine development.

Vaccines 98

Vaccines Medical Records Documentation Communication 98

Pharmaceutical Technology

NOVEMBER 3, 2022

There, Boehringer had earlier warned of the impending alteplase shortage in April 2022. After all, there have been united efforts before, pointing to the EU-wide Covid-19 vaccine procurement strategy as a good example, he says. Authorities from individual EU member states, like those from Czechia, have shared their individual warnings.

Documentation 111

Documentation Dosage Hospitals Vaccines 111

ISPE

OCTOBER 26, 2022

Wed, 10/26/2022 - 16:08. November / December 2022. 1 November 2022. ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Trudy Patterson.

Vaccines 97

Vaccines Compounding Documentation FDA 97

pharmaphorum

NOVEMBER 23, 2022

Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself.

Documentation 98

Documentation Dosage Hospitals Vaccines 98

Hospital Pharmacy Europe

JANUARY 19, 2023

Accompanying leaflets for patients have been developed and also digital versions of the documentation. Community pharmacists also need access to the full medical record both to read and to enter data such as records of flu vaccination, she added. Poster 008 presented at FIP Congress, Seville 2022. 07 September 2022.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

PQA

AUGUST 8, 2022

This guest blog is one in a series by sponsors of the 2022 PQA Annual Meeting on the utilization of the EQUIPP platform to promote performance improvement on medication-related quality measures while engaging transparency between health plans and pharmacies. PQS is excited to unveil the new EQUIPP® to all our partners premiering in Fall 2022.

Independent Pharmacies 52

Independent Pharmacies Community Pharmacies Patient Care Vaccines 52

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. GlobalData pharmaceutical analysts project that RNA-based gene therapies for oncology will grow from zero in 2022 to $4.6 billion by 2028.

Vaccines 52

Vaccines Documentation Communication 52

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Trudy Patterson. Cauchon, PhD.

Documentation 52

Documentation FDA Communication Packaging 52

pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

ISPE

SEPTEMBER 11, 2023

3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. PDA Journal of Pharmaceutical Science and Technology 75, no. 1 (2021):48. 3 a b c Algorri, M., Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.” Journal of Pharmaceutical Sciences 111, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 21, 2022

Mon, 11/21/2022 - 15:03. 21 November 2022. On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines. Trudy Patterson.

FDA 52

FDA Vaccines Documentation Dosage 52

ISPE

NOVEMBER 22, 2022

Tue, 11/22/2022 - 06:53. 22 November 2022. The 2022 ISPE Singapore Affiliate Conference & Exhibition featured a regulatory roundtable discussion on the Future of Pharmaceutical Inspections. Have all requested documents ready and easily accessible. ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections.

Documentation 52

Documentation FDA Vaccines 52

PharmaShots

JUNE 1, 2023

PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. Safety and clinical activity of the product were presented at ESMO 2022.

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40

Pharmaceutical Technology

SEPTEMBER 7, 2022

The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference. The company has cemented its position as a reputable partner for CROs, with several major players in the race to develop vaccines and treatments for Covid-19 trusting it with critical projects. It has translated more than 6.3

Data Entry 52

Data Entry Vaccines Documentation Labelling 52

The Happy PharmD

SEPTEMBER 15, 2024

Based on the data, the average distress level among pharmacists has decreased compared to previous reports spanning from 2019 to 2022. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. It has declined from 3.25 in 2019 to 2.59.

Documentation 52

Documentation Dosage Communication Insurance 52

The Checkup by Singlecare

MARCH 16, 2023

a clinical pharmacist at Walgreens in McKinney, Texas, and a 2022 Best of the Best Pharmacy Awards winner. Department of Health & Human Services (HHS) expanded pharmacy technicians roles to include administering vaccines and point-of-care testing during the COVID-19 pandemic.

Data Entry 52

Data Entry Long-Term Care Facilities Insurance Immunization 52

Hospital Pharmacy Europe

MAY 9, 2024

Over 70 graphics, including alternatives to handshakes and explanations of mRNA vaccines, were then created and published online by The Spinoff, a New Zealand news outlet. Earlier this month, the ECDC released a report based on a point prevalence survey (PPS) conducted in European acute care hospitals in 2022/23.

Hospitals 52

Hospitals Communication Clinic Management Documentation 52

ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. Trudy Patterson.

Documentation 52

Documentation FDA Packaging Communication 52

European Pharmaceutical Review

FEBRUARY 17, 2023

The European Medicines Agency (EMA) has released a report detailing its Human Medicines Highlights 2022. The document contains an overview of the agency’s key recommendations in 2022. The highlights document summarised the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkeypox).

Documentation 98

Documentation Vaccines 98