Qualitas

01/01/2024

Qualitas QA wishes you a Happy New Year

01/29/2023

What's new in regulatory science? The FDA will tell you...

01/21/2023

Food Fraud is an increasing threat to food quality and food safety and impacts the economy negatively. For the fiscal year 2020-2021, is was reported by the CFIA that 33.8 % of expensive oil samples tested were unsatisfactory.

Read more at https://inspection.canada.ca/science-and-research/our-research-and-publications/food-fraud-report/eng/1651594307095/1651594307580 -pg0

12/31/2022

We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Qualitas is your career opportunity. Qualitas is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


We are hiring a Manager Pharmacovigilance, Regional Lead
The resource will preferably be based in the EU, however, we are open to any candidate globally

Your Job

Lead handover activities from the customer to local Qualitas teams (partners/affiliates) during the implementation phase
Allocate the right level of local resources to each country ensuring deputization
Identify training needs and put in place induction plans if needed assigning a mentor
Coordinate and lead the communication with local teams in the region from the customer and Qualitas
Management of local teams and identification of resource/ staffing needs in the region
Identify issues for escalation in the region, reporting them to the LPVS Operational Lead and LPVS Program Manager
Responsible for timely and high-quality management of local pharmacovigilance and medical information activities in the region
Main point of contact for local PV teams as interface with all LPPVs / National PV Contact Persons (NCPs) in the region
Provide local project related trainings to local teams requested by the customer or Qualitas
Provide feedback into project-specific processes related to the management of local PV teams and implement those at the regional level.
Participate in regular team meetings with local PV teams and document with minutes and action plans.
Oversight of local PV activities at the regional level and providing support to local teams based on activities described in the Project-specific customer process documents and requirements.
Identify opportunities for continuous improvement
Your Profile

Master’s degree in medicine, pharmacy, natural science
Proven experience in local pharmacovigilance activities at the affiliate level (5+ years PV experience)
Proven experience being LPPV or National PV Contact Person (NCPs)
Detailed knowledge of the applicable legislation
Experience with management and steering of projects
Clear understanding of client needs
High affinity to work with complex business processes
High sense of responsibility and self-motivation
Ability to adapt flexibly to changing project conditions and open to change management processes
Capability of supervision, prioritisation, and processing of parallel projects and tasks
Excellent team player
Complex problem solving, strong understanding of business
Structured, analytical, systematic, and independent manner
Autonomous, concentrated, and high-quality work
Very good written and spoken communication skills with internal and external customers, stakeholders, colleagues, and supervisors
Experienced user of the MS-office packages
Very good command of English
We offer

Opportunity to conquer exciting and varied challenges alongside a talented team
Flexible working hours (remote work possible)
Open and collaborative organizational culture with an emphasis on knowledge-sharing
Business interaction with nearly all branches of the company across 5 continents
A broad range of initiatives for personal development and professional training
The opportunity to grow in clinical safety field in the company

If you are interested in joining our Qualitas team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us.


Agencies only by prior agreement for the specific job opportunity.

06/17/2022

Qualitas is pleased to offer a new webinar in cooperation with Pharmalex: Better information, better decisions for your access strategy – Inmediata powered by SmartPHLEX a new platform.

INMEDIATA is aimed at anybody interested in advance information on potential changes in the pharmaceutical market in order to formulate forward-looking strategies. To learn about the information collected in the new platform (INMEDIATA) and how to use it to generate trend analysis of future drug approvals as well as drugs undergoing P&R procedures in Spain.

Date: June 16, 2022

Time: 02:30 PM CET

Duration: 1 hour(s)

Register at https://go.pharmalex.com/pharmalex-webinar-inmediata-market-access-strategy-tool?utm_source=Website_PLX&utm_medium=Webinar&utm_campaign=Innovations

10/31/2021

Are you ready for the next inspection?

Are you concerned about your upcoming Regulatory Inspection? How do you prepare for it and prepare your Subject Matter Experts (SMEs)? Is your Inspection Readiness Plan in place?

The development of a detailed Inspection Readiness Plan will reduce your concerns and help you work towards a successful Inspection outcome.

Your Inspection Readiness Plan should involve a cross-functional team of the appropriate level of personnel in your organization. This team is key to ensuring the site is prepared for the Inspection and ensuring identified actions are completed in advance of the Inspector arriving on site. The Plan should include details of the logistics of the Inspection i.e. what room it will take place in, where the war room or back-up room will be located, who the scribe will be etc. Other items to consider in the lead-up to the Inspection are your SOP for handling inspections, identifying and preparing the SMEs, and identifying the main areas of weakness in order to practice delivery of the site position.



Review your Handling of External Inspections SOP. It should include:

Details relating to notification of an inspection to the site team (for announced inspections) once received from the Health Authority.
For an unannounced inspection, a mechanism for notification of the Inspector’s presence on site.
Details on how document flow will be managed e.g. communication of a request to the wider team, review of a document prior to submission to the Inspector and control of original and any copied documents, if provided, to the Inspector.
Details on how the record of the Inspection should be maintained; this should include the documentation and version number provided to the Inspector, details of any documentation taken off site by the Inspector, daily scribe notes, list of personnel met and the opening and closing meeting minutes.
Identification and Preparation of Subject Matter Experts.

Remember that the most technical person may not be the best person to place in front of an Inspector. FDA Inspectors are trained to interrogate and investigate and draw conclusions from what they are told. They are technically competent in their area of inspection and are particularly strong in interrogating and eliciting information. Therefore, select your SME carefully. It is key that you understand the FDA interrogation techniques and simulate inspection interviews in preparation.

Ensure the SMEs understand the different questioning techniques used. Closed-ended questions will elicit a Yes/No answer e.g. Was a deviation raised for this? Open-ended questions on the other hand can elicit a lot of information e.g. “Tell me about this deviation.” A leading question could be “Do you believe this deviation was handled appropriately?”. The inspector could make an assumptive question e.g. “Is a deviation not required to be raised for minor non-conformances?” where they are making an assumption in asking the question.

The SMEs should always answer with a fact-based response, never an opinion! A system overview in a policy or procedure maybe used during the Inspection response to help support the response. Remember, responses are never off the record i.e. during lunch time or towards the end of the week when the Inspector appears more casual or relaxed. The SME must remember this is an official inspection at all times. Answer the specific question and stop speaking! This maybe hard, particularly if there is a silence. The SME should never feel they have to fill that silence! Listen to the question properly and reword the question to confirm your accurate understanding of the question. And….Always tell the truth. Training sessions should be carried out to simulate an inspection setting and ensuring your SME is prepared appropriately.

Identify your areas of weakness in advance so they can be corrected or prepared.

If an issue can’t be eliminated in its entirety, prepare how the Company shall discuss the issue in a way that clearly represents how the issue was identified and how it was, or is being addressed. What are the major deviations that occurred since the last inspection? Are you satisfied with the manner in which they were closed? Were the CAPAs appropriate and effective? Have you assessed your CAPA effectiveness? What risk assessments have been completed? Are you comfortable defending your risk approach? Where there are action plans still in place, can you show the timeline of actions and progress to date using the appropriate quality system?

10/07/2021

Curious about pharmaceutical developments and resources?

Some of the useful publications are:

American Pharmaceutical Review: An important journal for technology in the pharma industry in North America, including news in: drug delivery, IT, R&D, manufacturing and regulatory affairs.

uCheckOrphan: A useful resource of treatments, clinical trials, R&D news.

EFPIA: The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharma industry in Europe.

Fierce Biotech

Fierce Pharma: https://www.fiercepharma.com/ provide many resorces including information about industry events, trending topics, webinars, virtual events and more.

Fierce Biotech: https://www.fiercebiotech.com/ is the equivalent in the biotech world

GaBI Journal: Generics and Biosimilars Initiative was founded in 2008 by Pro Pharma Communications International and aspire to improve the status of generic and biosimilar medicines. Here you can find information about generic and biosimilar medicines in an open access format.

G.I.T. Laboratory Journal: This journal is for all user currents in the industry - not only laboratory personnel. It provides current information in numerous topics including trending topics and guidelines.

Life Science Leader: This digital version of this business journal for life science executives is designed to provide thought leadership and an in-depth look into industry trends and hot topics that will impact the growth of the pharma and biopharma markets.

Nature Biotechnology: The Nature Research portfolio includes journals, online databases, and services across the life, physical, chemical and applied sciences and clinical medicine. Focusing on the needs of scientists, Nature (founded in 1869) is the leading weekly, international scientific journal. Online, nature.com provides over 6 million visitors per month with access to Nature Research publications and online databases and services.

Nordic Life Science Review: Available in both physical and digital versions, this publication aims to build bridges between readers of industry by providing them with the latest developments, progress and setbacks, in-depth stories and interviews from the Nordic countries.

Pharmaphorum: pharmaphorum is a content and communications company that offer a unique hybrid combination of publishing heritage and journalism with the creativity and expertise of an agency. As a Google-recognised source of “real” news and information, pharmaphorum works with global pharma companies to apply this expertise in publishing, journalism and content-development.

Pharmaceutical Commerce: Written for biopharma commercial executive decision-makers focusing on business processes and the technologies involved in how approved drugs go to market, with the goal of reducing the cost of commercial operations. The online version of this magazine features special web only content as well as all the content available in their print version.

Pharmaceutical Manufacturing: aims to help drug makers understand and improve their processes, and gain manufacturing efficiencies, improving speed to market within the highly regulated Pharma environment.

Pharmaceutical Online: Pharmaceutical Online provides the pharmaceutical manufacturing and packaging industry with exclusive and actionable information to help industry members tackle the challenge of bringing life-saving and life-improving therapies to market.

PharmTech Talk | Pharmaceutical Technology: For biotech professionals looking for dynamic and reliable cutting-edge peer-reviewed content on next-generation process, pharma Tech is best resource for topics including development and manufacturing, formulation, drug delivery, ingredients, regulation, analytics, packaging, supply-chain, and outsourcing. They also provide comprehensive coverage of international regulations and business trends relating to drug development.

Pharma Times: PharmaTimes offers a blend of news stories, interviews, features, case studies, analysis and comment on the critical issues facing the pharma and healthcare sectors. Its wide editorial lens combined with its editorial philosophy to deliver coverage from the perspective of the industry, the payer and the patient allows PharmaTimes to help kickstart conversations that matter most to our audience of decision makers within pharma and the healthcare profession.

PharmaVoice: The primary audience for PharmaVoice is made up of executive and corporate management from pharmaceutical, biotechnology, drug delivery, marketing communications, clinical services, contract research, drug development, and information technology companies, as well as other industry sectors. PharmaVoice has readers from around the world.

SciDoc Publishers: SciDoc Publishers is established with a sole motive to disseminate knowledge among the scientific community. Its publishing model allows them to reach millions of readers and give them access to scientific publications - online, free of charge. Through Open Access, it intends to remove all barriers that traditional publishing models impose. Keeping up to the pace of the 21st century and the vast global research scenario, it ensures accelerated distribution of new developments to the entire scientific community.

Securing Industry: SecuringIndustry.com is an information service that covers the issues surrounding supply chain. It provides practical advice and intelligence to help manufacturers define and pursue their own strategies for tackling crime including counterfeiting, product diversion, adulteration and theft. We cover key developments in the major areas of supply chain like cargo thefts, shipment security and developments in the global regulatory environment.

Stat News: Stat News delivers fast, deep, and tough-minded journalism about life sciences and the fast-moving business of making medicines. It takes you inside academic labs, biotech boardrooms and political backrooms. It casts a critical eye on scientific discoveries, scrutinizes corporate strategies, and chronicles roiling battles for talent, money, and market share. It covers the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human healt

10/03/2021

Environmental monitoring - best practices in food safety

Establishing a comprehensive environmental monitoring plan can help facilities take a preventative, proactive approach to correcting potential food safety testing issues.

Education and awareness about the measures your facility can take help ensure food safety. In this series, we explore best practices for implementing an effective environmental monitoring program using our Environmental Monitoring Handbook. This resource has been developed with Cornell University and other industry experts. It provides guidance on how those in the food and beverage industry can build and implement a holistic approach based on scientific advice and industry best practices.

In this article, we look at an essential part of this preventative approach, namely testing for indicator organisms and pathogens in food processing environments. These monitoring methods can be used to determine the general hygiene of food processing areas.

Testing for indicator organisms.
Indicator organisms are a group of organisms that reflects the general microbiological condition of a food or the environment. Indicator organism monitoring is conduced to help monitor or validate sanitation and process controls. It provides information about the microbial ecology of food manufacturing areas and assesses post-processing contamination risk The microorganisms tested represent the overall condition of the food environment where the food is being processed.

Aerobic Plate Count (APC), or Total Plate Count (TPC), is one of the most common indicator tests. It provides information about the total population of bacteria present. Simply put, if a manufacturing process is under control, the number of indicator organisms will also be in control. APC counts above a certain threshold suggest that the sanitation of that specific environment was ineffective and/or improperly performed.

Enterobacteriaceae consists of a diverse group of bacteria including coliforms and some pathogens such as Salmonella.

Enterobacteriaceae testing serves the same purpose as coliform testing in that it indicates:

Improper cleaning
Unsanitary conditions
Post-process contamination
Testing for pathogens.
Pathogen tests check for the presence of a specific microbe. Because this microbe can be difficult to find, it is recommended that additional methods be used to validate cleaning and sanitation procedures, such as adenosine triphosphate (ATP) tests and total plate count.

The primary goal for pathogen environmental monitoring programs is to eliminate pathogens and the associated risks for foodborne illnesses and recalls. Foodborne pathogen contamination of finished products typically occurs at a low frequency, which can make finished product testing alone an ineffective strategy for ensuring food safety. Using a pathogen environment monitoring program can help identify contamination sources before they reach a finished food product.

3M pathogen testing.
LEARN MORE.
Environmental monitoring is typically used in facilities that process ready-to-eat (RTE) products or in facilities that handle RTE products. While many different pathogens can cause foodborne illness, only a few are linked to food processing and handling environments. Key pathogens targeted for environmental monitoring programs include Listeria monocytogenes, Salmonella, and Cronobacter spp.

For both indicator organisms and pathogens, a program should be established with sampling procedures and frequency, appropriate test methods, results interpretation, and corrective action procedures. Frequency should be determined and may vary between facility, commodity, and target analyte. Sampling sites should be mapped out with the goal of finding potential issues in the most likely sources of contamination. Quantitative results will be useful in establishing baselines and identifying trends over time.

09/13/2021

The FDA holds a workshop about how it conducts postmarketing drug safety surveillance and how adverse event reports are collected, analyzed, and communicated to the public during a free CE webinar on September 28 at 1PM EST.

Register here:

On Tuesday, September 28, 2021, at 1pm (ET), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: FDA’s Role in Postmarketing Drug Safety Surveillance. This webinar will provide an overview on how the FDA conducts postmarketing drug safety...

09/13/2021

ICYMI: Join FDA on Sep. 21-22 for the public workshop on how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide & facilitate generic drug development, regulatory assessment, & approval.

Register at

Advancing Generic Drug Development: Translating Science to Approval

09/13/2021

The guidance “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers,” has been revised by the FDA. It was originally published in April 2021.

09/13/2021

Covid-19 exposes weak pharmaceutical supply chain

A study by the Center for Analytics and Business Insights (CABI) highlights the vulnerability of the pharmaceutical supply chain that has come to light during the Covid-19 pandemic. The study by CABI at Washington University’s Olin Business School has reveals that more than 80% of APIs for essential drugs are not manufactured in the US. India and China supplies most of the APIs essential for pharmaceutical manufacture and medicine supply in the US and worldwide.