Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

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Documentation Communication 52

Eye on FDA

OCTOBER 19, 2022

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform.

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Communication Documentation 89

FDA Law Blog: Biosimilars

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic had changed the way people live, work and communicate. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.

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Communication Biosimilars Documentation 53

FDA Law Blog: Biosimilars

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Timeline Section 524B became effective on March 29, 2023.

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Documentation Labelling Communication 105

FDA Law Blog: Biosimilars

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023. There are drawbacks to the current communication channels: 1.)

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Documentation Labelling Communication 59

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

Documentation 52

Documentation Packaging Communication Customer Service 52

FDA Law Blog: Biosimilars

AUGUST 9, 2023

48365, 48369 (July 27, 2023). Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies.

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Controlled Substances Documentation Communication 52

Pulses

JUNE 6, 2023

By: Melissa Mickley 2023 PharmD candidate If students hate it so much, why do we keep doing it? This helps them to connect even outside the classroom to communicate about questions they may have and creates a stronger support system. Accessed January 10, 2023. Accessed January 10, 2023. Accessed January 10, 2023.

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Documentation Communication 105

PharmaState Academy

MARCH 30, 2023

He is an awe-inspiring peronality who has exceptional experiences in building and leading Institutional Sales, Key Account Management , Strategy & Planning , Market Access, Tender Business, New Product Inclusion, Document & Pricing strategy and much more.

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Documentation Communication 52

FDA Law Blog: Biosimilars

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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Documentation Communication 45

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

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Documentation Method Validation Packaging Labelling 52

ID Stewardship

MAY 12, 2023

BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Knowing how the RPD communicates is important.

Communication 52

Communication Documentation Vaccines 52

RX Note

MAY 8, 2023

#DraftingStill#Writing#Preview Introduction The moment I started work on this idea, I realized smartphones has integrated with many aspects in our life, such as communication, finance, maps and navigation and shopping. There are so may choices to pick from and the choices are subject to our own preferences.

Communication 52

Communication Documentation 52

pharmaphorum

FEBRUARY 28, 2022

UK Health Secretary Sajid Javid has said he wants to accelerate the rollout of electronic patient records (EPR) in the NHS, with 90% of NHS trusts using them by the end of 2023. Other digital initiatives will include greater use of remote monitoring of patients to allow them to be cared for in their own homes.

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Documentation Communication 110

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 References European Commission, (26 April 2023). Euractiv (6 October 2023).

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Packaging Documentation Communication Pharmaceutical Companies 82

epicur

AUGUST 8, 2023

It was a busy first six months of 2023 for veterinary professionals and practices, and the rest of the year isn’t likely to slow down. The system lists what you can order for office stock and will provide the documentation necessary for patient-specific orders if the guidance requires it. It often starts with communication.

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Compounding Documentation Compounding Pharmacies Packaging 52

Integra X Files

DECEMBER 19, 2022

The document also requires plans to provide a transition period for non-formulary drugs to ensure beneficiaries have continuous access to required medications. In its LTC Guidance Document, CMS instructs plans to make efforts to reach out to LTC pharmacies to advise them of network pharmacy participation.

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Nursing Homes Documentation Dosage Packaging 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Documentation Labelling Communication 45

Digital Pharmacist

NOVEMBER 21, 2022

b) Marketing and Communications Oversight. Medicare beneficiaries will be secured by CMS’s finalization of revisions to marketing and communications regulations that will guarantee they get accurate and understandable information about their coverage. Remind patient regarding preventive services and other communications.

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Communication Documentation Pharmacy Management Immunity 98

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Nat Biotechnol. Injection Safety Fact Sheet. Internet] WHO.

Vaccines 99

Vaccines Communication Immunity Immunization 99

GMPSOP

JULY 14, 2023

Additional documents included each month. Additional documents included each month. Cleaning requirements for dedicated equipment may be less than those for common equipment, provided the company has documented either the maximum number of batches or the maximum time that can elapse before complete cleaning must be done.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Flip the Pharmacy

MAY 5, 2022

Meanwhile, the pharmacist communicated with the patient's primary care provider on all of the previously mentioned findings. Collaborating with schools of pharmacy and meeting patients where they are in the community (i.e., senior centers) is another modality to providing high level care for our community members.

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Documentation Diabetes Communication 52

Quality Matters

AUGUST 3, 2023

Supplier disqualification : If a supplier no longer meets the approval criteria, the team should disqualify the supplier and remove it from the supplier list so long as these actions are thoroughly evaluated and documented to minimize the impact on product quality and supply disruption.

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Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

Quality Matters

JUNE 21, 2023

Risk assessment, communication, and mitigation through post-marketing surveillance are also important steps in the process. josh.levin@usp.org Wed, 06/21/2023 - 10:53 Supply Chain However, a potential lack of access to adequate quality control laboratories can inhibit corrective actions, such as product recalls.

Communication 52

Communication Vaccines Documentation 52

ID Stewardship

APRIL 13, 2023

BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

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Hospitals Inpatient Documentation Communication 94

Express Pharma

DECEMBER 11, 2023

The latest in this series, Chandigarh Pharma Summit 2023 was successfully hosted by Express Pharma recently. In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.

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Packaging Communication Documentation 96

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Packaging Documentation Labelling Communication 59

Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). Translational Medicine Communications, 4(18). autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., [link] 2 Aiyegbusi, O., Macpherson, K., Washington, J., Newsome, P., and Calvert, M. and Kumar, P.

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Communication Documentation Drug Development 40

European Pharmaceutical Review

SEPTEMBER 13, 2023

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.

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Communication Documentation 74

Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

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Insurance Coverage and Processing Communication Documentation Diabetes 40

GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer? Additional documents included each month. Subscribe b.

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Documentation Dosage Communication Method Validation 52

Putting Patients First Blog

MARCH 13, 2023

NHC Comments on Interoperability and Prior Authorization Proposed Rule (PDF) March 13, 2023 The Honorable Xavier Becerra Secretary Department of Health and Human Services 200 Independence Avenue S.W. Washington, D.C., 20201 Re: CMS-0057. It would be helpful if CMS were to develop a national consistent set of denial codes.

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HIPAA Hospitals Documentation Communication 40

European Pharmaceutical Review

NOVEMBER 9, 2022

Another factor in this enhanced adaptability is development of in-house expertise that enables more efficient interaction by simplifying communication channels. Technology transfer of the process from development to manufacturing involves generating a wide variety of documentation, data and training.

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Vaccines Documentation Communication Hospitals 95

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. 10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes.

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Drug Pricing Drug Development Documentation Communication 40