The FDA’s Office of Pharmaceutical Quality (OPQ) is working to encourage the development and adoption of emerging technologies in the pharmaceutical industry that have potential to enhance drug product quality. To achieve this goal, OPQ established the emerging technology team (ETT) program and focuses on advancing regulatory science for emerging technologies. OPQ has identified Continuous Manufacturing as one such emerging technology which has the potential to increase the efficiency, flexibility, agility, and robustness of pharmaceutical manufacturing. The ETT provides industry early engagement opportunities with FDA to receive feedback on potential technical and regulatory issues and FDA’s recommendations for regulatory submission content related to continuous manufacturing and other emerging technologies. In addition, OPQ has started a regulatory science and research program on continuous manufacturing to address remaining gaps in our knowledge and experience. Our research program is currently focused on the following areas in (1) integrated process modeling, (2) understanding of the impact of material properties, and (3) implementation of advanced process control strategies and real time release testing. The results and knowledge developed in this program can be utilized to support the implementation of continuous manufacturing and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science.Read more >
Topics and discussion points include:
Regulations: What are the most often cited violations? Are pharma marketers getting better at compliance? Cautionary tales – beware of agencies with limited regulatory experience.
Ethics: Why are ethics in marketing important? What ethical principles should pharmaceutical marketers obey, especially in the digital realm? A bit of history: The eHealth Code of Ethics
Transparency: Do you have a transparency policy? Is transparency good in theory, but not in practice?
Patient Power: How are patients affecting pharmaceutical marketing? Mining the views of patients via social media to guide you marketing efforts.
Digital: How digital media and mobile are disrupting pharma marketing and what to do about it. What digital marketing channels are preferred by physicians?
Alexza Pharmaceuticals, Inc. AwardRead more >
The Asia Pacific is the third largest pharmaceutical market in the world after North America and Europe, with generics being the major driver for the pharmaceutical industry in this region, aided by factors such as the aging population and impending expiry of patented drugs. It is a necessity for pharmaceutical companies to be aware of the key trends in the APAC generics market and maximise the market opportunities in order to remain relevant.
In today’s rapidly evolving business landscape, pharmaceutical companies are also starting to realise the importance of the customer experience as a key differentiator. With a gradual shift from product to the customer, the pharmaceutical industry needs to keep up with other industries in terms of providing the perfect digital customer experience. A well-executed digital strategy is essential for today’s pharmaceutical companies to better connect with their clients.
Join us as we discuss these and other key topics.
Together Chemir Analytical Services and Nature's Fingerprint can provide highly-precise assessment of potential counterfeit pharmaceutical products and, more significantly, protect the highly-valuable process-patent intellectual property of pharmaceutical and biotechnology firms, potentially extending the drug patent life by a number of years.
This webinar will introduce cutting edge technology used for pharmaceutical process and product authentication. Learn how this technique:
-- "Rounds off the patent cliff" to extend effective patent life
-- Defends against counterfeit drugs by "fingerprinting" chemical processes
Janssen Pharmaceuticals, a member of the Johnson & Johnson family of companies, transformed their medical information contact centers to deliver a faster, more seamless customer experience. Join this webinar to learn how using the Salesforce Service Cloud and Knowledge allows Janssen to:
-Successfully manage a medical information solution across the pharmaceutical and medical device sectors of Johnson & Johnson
-Increase agent productivity by automating 99% of processes for the medical device center
-Improve agility and innovate on top of the Salesforce platform
-Respond to customers 25% faster on their medical information requests
The CRO+Consultant+Sponsor Relationship: Collaborating to Ensure Sponsor and Client Success.Collaboration is the key to a successful consulting partnership. This webinar will focus on the responsibilities and perspectives of key stakeholders (Sponsor, consultant and CRO), how to make the most out of the Sponsor/consultant relationship, and key considerations when partnering with a contract research organization. Explore ways to optimize your consultant relationships to ensure success!Read more >
The principal benefits of continuous processing are considered to be reduced cost, increased speed, agility and quality. Use of such technology for pharmaceutical products is in its relative infancy despite the existence of appropriate processing platforms. Notable perceived barriers to the use of continuous manufacturing are with the initial capital spend, regulatory uncertainties and low technical competence limiting its uptake. This presentation provides details of early experiences with continuous drug product manufacture in the pharmaceutical industry and identifies areas of focus which is believed will drive adoption of this technology for the benefit of future pharmaceutical production.Read more >
As the number of doctors willing to see pharmaceutical sales representatives in person declines how can digital tools help with access, reach and rep effectiveness?
One of the factors blamed for the reduction in access was digital preferences – particularly among younger doctors.
However, digital interactions – though clearly on the rise – can will never entirely supersede face-to-face contact, so how can the industry best get the digital/face-to-face mix right?
This PMGroup webinar, in association with M3 Europe and Veeva Systems, will look at the place of sales reps in the digital age and how best to support them with digital tools and channels.
Making the Impressional Personal: Best Practices for Customizing Non-personal Promotion. Interview with Darshan Kulkarni, Leif Goranson, Tom Jones. December 4, 2015 Philadelphia. By Pharmaguy John Mack.Read more >
Advances in KOL Intelligence are delivering richer insights into clinical landscapes than ever before. The pharmaceutical organisations which harness these insights to inform strategic planning will be better able to meet the challenges of an increasingly competitive and complex environment for KOL Engagement. There’s a wealth of information out there, but it’s not all about Big Data – it’s about smart data and insight that you can easily act on.
Is your KOL Intelligence a mass of data, or is it a tool that broadens your understanding of influence and helps you make smarter decisions? Can you confidently identify who’s suitable for ad boards? Are your network maps simply impressive graphics, or a tool for better engagement? Or are you new to KOL intelligence and looking for guidance on where to begin?
As the pioneers of KOL mapping and the UK's leading KOL intelligence agency, we believe the strength of our work doesn't simply lie in the quality of our research, but in how we help our clients understand it. If you’re new to KOL intelligence we’d like to show you what you can learn. And if you already know how valuable it is, you’ll understand how important it is to stay on top of the latest trends in KOL analysis.
On May 13th, at 12pm (GMT), in association with PMLiVE, Kendle Healthcare will host a free webinar, “Next-generation KOL Intelligence: Better insight, better outcomes”, which will help you understand how to use KOL intelligence to make better-informed decisions. Our webinar will be interactive and we welcome any questions you may have.
New reimbursement models, clinical technologies, and consumer expectations are driving life sciences companies to rethink how they improve the patient experience.
Hear Salesforce’s industry leaders share innovative approaches to supporting patients. See a live demonstration of how your organization can deliver patient-centric care through their journey onto pharmaceutical and device therapies.
A comprehensive two-dimensional liquid chromatograph (LC × LC) was constructed from commercially available conventional HPLC equipments. This system utilizes two independently configurable 2nd dimension binary pumping systems to deliver independent flow rates, gradient profiles and mobile phase compositions to dual Fused-Core secondary columns. Very fast gradient separations (30 seconds total cycle time) were achieved at ambient temperature without excessive backpressure and without compromising optimal 1st dimension sampling rates by using superficially porous stationary phases. A practical approach to optimize the various inter-related instrumental parameters will also be presented.Read more >
Living with any chronic health condition can be demanding, but rare diseases bring a unique set of challenges for patients.
These can range from diagnosis difficulties to limited information and support, a lack of knowledge - even within medical services - and social stigma. Such challenges negatively impact patients and carers - preventing the best possible health outcomes from being achieved.
This webinar will help pharmaceutical companies understand how they can better address the unmet needs of such patients.
On Tuesday 15 July at 2pm this free event will feature a health psychology specialist and a patient research expert, who will discuss how a ‘belief-based’ support approach can be delivered.
The webinar will also investigate how a long-term strategy that accommodates the changing support needs of individual patients from childhood to adulthood can be delivered at a global level – while still resonating at an individual level for patients.
A pharmaceutical industry multi-stakeholder interactive discussion on some of the unique challenges faced today in marketing pharma brands effectively to exploit areas of unrealised opportunity, plus what is required from both strategic marketing and research to deliver in view of this.Read more >
The regulatory needs of GMP (Good Manufacturing Process) require documentation covering all aspects of manufacturing – including IT systems and infrastructure such as networks, servers, software, etc. Accurate, maintained IT documentation is a common weak point because of the complexity, but auditors don’t care when it comes to signing off compliance. In this webcast Bob Camerino of ITS will cover the typical scope and types of information covered by CDM (Compliance Documentation Management) and efficient methods of maintenance.Read more >
Webinar featuring InnoCentive Founder Dr. Alpheus Bingham, as he shares case studies from pharmaceutical companies that used crowdsourcing as part of their drug discovery efforts.Read more >
Attend this presentation as Carwyn Jones, Head of Pharmaceutical Sales and Marketing, Doctors.net.uk shares data/research relating to how you can engage with a doctor online. With some interesting data relating to how to establish trust online, engage with doctor specialties, and provide tools online that are “sticky”, Carwyn will highlight how “collaborating” with doctors is crucial in the online world.
- How to develop trust with doctors.
- How to establish engagement with doctors as opposed to “one hit”
- Understanding what doctors want
- How is Pharma currently engaging with doctors online
- The pitfalls when developing digital assets.
Watch our latest webinar on the Pharmaceutical & HealthCare Marketing BrightTALK channel: Global Growth Markets CEO Pete Read talks about Indonesia’s healthcare market fundamentals, the challenges faced, improvements in progress, how technology can help and opportunities for investment.Read more >
Recent global survey data confirms that pharmaceutical sales representatives are still doctors’ preferred source of pharmaceutical product information. Although doctors are increasingly using social media and other online channels in their professional capacity to search for and share information, face-to-face interactions still carry more trust and are more likely to influence prescribing. While pharma shouldn’t neglect digital channels as potentially valuable entry points for the promotion of assets, more meaningful and impactful marketing strategies will be those that pursue an optimal mix of face-to-face and digital initiatives.Read more >
The life sciences industry has changed dramatically in the last decade. The world of blockbuster drugs and treatments that are bought by a huge portion of the population has shifted to one in which micro-segments of the population are buying highly targeted treatments for their specific needs. Furthermore, a changing regulatory atmosphere requires that life sciences companies effectively target the right providers with the right information for the right people. As a result of this shift, simply logging calls and medical inquiries is not enough. Now Analytics, embedded within every application, is necessary to drive the right solution for the right provider and the right patient, at the right time.
Want to understand the cutting edge of how this can impact your life science business? Tune into this webinar to learn from experts within the Life Sciences Practice at Deloitte Consulting and Salesforce on the state of the art of how Wave Analytics - the best analytics for Salesforce is helping to drive forward a new world of hyper targeted medicine.
Most life sciences companies are challenged with meeting European Medicines Agency’s Identification of Medicinal Products (IDMP) regulatory requirement in 2016, especially since the standard hasn’t been finalized!
While many are taking a wait and see approach, others are getting a jump start in figuring out the 5Ws about the data necessary to comply and beginning to execute a plan for success. This means both domain expertise and technology.
Attend our upcoming webinar to learn:
the Who, What, When, Where and Why about IDMP
how to get started given the standard has not been finalized
how utilizing cloud-based solutions speed up data integration and aggregation, and
how IDMP provides the on-ramp to address broader data management and regulatory compliance strategies.
There is very little time for those governed by the mandate to design and implement the enterprise-wide data management processes needed to aggregate, cleanse, validate and ultimately syndicate product data..