Press Releases

Sylogent Launches Information Management Tool for Pharmaceutical Industry

Newtown, PA, August 2, 2016 (Newswire.com) - Sylogent, a software and data services company, has announced the formal launch of PROJECTIC for the pharmaceutical industry. The web-based process management tool is designed to visualize milestones, projects and tasks across the enterprise with the push of a button. PROJECTIC is a flexible tool that allows for repetitive structured processes to be saved as templates that are managed by key data points.

“New global transparency regulations mandate that increasing amounts of information and data must be submitted or published within very limited timelines," stated Jack Yeager, CEO of Sylogent. “PROJECTIC allows for system-driven process management to simplify the planning, tracking and resource forecasting for compliance of critical information.”

PROJECTIC has been deployed at several pharmaceutical companies to assist with study registration, clinical data disclosure and publication planning. Additional templates are being configured to assist with regulatory submissions, narrative processing and medical information. The stand-alone software is configured to import data from excel spreadsheets or any source system. The tool is integrated with Sylogent’s structured information platform, SYQUENCE, and other products including: CTD PUBLISHER, PUBSTRAT, CONFERENCE AUTHORITY, JOURNAL SELECTOR and clinicaltrials.gov.

“We believe PROJECTIC is exactly what pharma needs to ensure that evolving regulatory compliance milestones are achieved within departments and across the organization,” said Yeager.

To learn about PROJECTIC, visit projectic.com or email solutions@sylogent.com

About Sylogent

Sylogent develops software that maximizes regulatory compliance, reduces operational costs and optimizes resource value. We leverage an integrated knowledge of process, data, technology and people to design solutions that deliver measurable results.

To learn about Sylogent, visit sylogent.com or email solutions@sylogent.com

Source: Newswire

LOCATION

Newtown, Pennsylvania

DATE

August 2, 2016

Sylogent Launches Structured Data & Information Management Platform for Pharmaceutical Industry

Newtown, PA, August 2, 2016 (Newswire.com) - Sylogent, a software and data services company, has announced the formal launch of SYQUENCE for the pharmaceutical industry. The web-based system is designed to organize, standardize and automate the data necessary to produce critical information.

SYQUENCE is a flexible middleware tool that allows for structured data-driven processes to be implemented with minimal business interruptions. Integrated structured templates automatically create structured documents that maximize data consistency within a department and across the organization.

“With more regulations, fewer resources, smaller budgets and shorter compliance timelines, the industry must begin to automate their information processes,” stated Jack Yeager, CEO of Sylogent. “They cannot continue to manually process this heavily regulated information that ultimately must be consistent across the organization and public domain.”

SYQUENCE has been deployed at several pharmaceutical companies to assist with study registration, clinical data disclosure and publication planning. The single Study Master Form automatically creates all of the required registration and data disclosure documents populated with shared data elements. The system also creates a publication study document that includes study data needed by publication teams.

“Too much critical data is being managed in spreadsheets, word documents and within emails on laptops and desktops. Pharma must operate in real time if they expect to satisfy growing compliance regulations,” said Yeager.

To learn about SYQUENCE, visit syquence.com or email solutions@sylogent.com

About Sylogent

Sylogent develops software that maximizes regulatory compliance, reduces operational costs and optimizes resource value. We leverage an integrated knowledge of process, data, technology and people to design solutions that deliver measurable results.

To learn about Sylogent, visit sylogent.com or email solutions@sylogent.com

Source: Newswire

LOCATION

Newtown, Pennsylvania

DATE

August 2, 2016


Events

Sylogent continues to take its software products to pharmaceutical events around the world. Company CEO Jack Yeager also speaks at many of these events (*).

2017

Clinical Trial Disclosure & Data Transparency

Transparency of clinical trial information is taking on new dimensions, including the release of anonymized participant-level data and return of results to study participants. Clinical trial sponsors and academia are facing a host of new registration requirements in the US and EU. Organizations, such as the Institute of Medicine, WHO, and NIH are calling on both industry and academia to share their clinical trial data. Industry’s initiatives on data sharing are also expanding. This increased transparency and use of information from clinical trials brings with it new data use opportunities and operational challenges for industry and academia.

LOCATION

Phildelphia, PA

DATE

January 18-19, 2016

EVENT DETAILS

ISMPP Publication Planning

To be effective, medical publication professionals must stay current with the continuous evolution of guidelines and regulations, occasionally make judgment calls on ethical “grey areas,” and navigate a changing landscape while upholding good publication practices. To help members meet these challenges, this year’s meeting dispenses with the theoretical and focusses on the practical skills that drive successful publication delivery.

LOCATION

London, England

DATE

January 17-18, 2017

2016

EVENT DETAILS

DIA Disclosure & Data Transparency

Both U.S. and international markets have seen new regulatory reporting standards established in recent months, the most conspicuous being the Identification of Medicinal Product standards in Europe. It is more important than ever for regulatory operations professionals to be able to accurately gather and compose compliant submission documents. But this process is always highly challenging, as it is strongly impacted by the silo effect and by operational deadlines of multiple different teams.

LOCATION

London, England

DATE

December 6-8, 2016

EVENT DETAILS

Sponsors Publication Planning Event

As new developments emerge to enhance transparency, pharmaceutical companies are faced with changing clinical trial disclosure regulations, results posting requirements and data sharing responsibilities. CBI’s Publication & Clinical Trial Disclosure Congress is the only life sciences forum that convenes publication and disclosure professionals to address how to improve the coordination and consistency of results postings in registries, journals and patient communications.

LOCATION

Barcelona, Spain

DATE

December 7-8, 2016

EVENT DETAILS

Clinical Regulatory Operations & Outsourcing Summit

Both U.S. and international markets have seen new regulatory reporting standards established in recent months, the most conspicuous being the Identification of Medicinal Product standards in Europe. It is more important than ever for regulatory operations professionals to be able to accurately gather and compose compliant submission documents. But this process is always highly challenging, as it is strongly impacted by the silo effect and by operational deadlines of multiple different teams.

LOCATION

Philadelphia, Pennsylvania

DATE

July 11-12, 2016

EVENT DETAILS

Global Regulatory Updates on Data Sharing, Results Postings and Lay Summaries

As new developments emerge to enhance transparency, pharmaceutical companies are faced with changing clinical trial disclosure regulations, results posting requirements and data sharing responsibilities. CBI’s Publication & Clinical Trial Disclosure Congress is the only life sciences forum that convenes publication and disclosure professionals to address how to improve the coordination and consistency of results postings in registries, journals and patient communications.

LOCATION

Barcelona, Spain

DATE

June 22-23, 2016

EVENT DETAILS

Medical Publications in a Data-Rich World: Enhancing Quality and Transparency

We are pleased to present the final program for the 12th Annual Meeting of ISMPP, Medical Publications in a DataRich World: Enhancing Quality and Transparency. Meeting sessions will highlight the increasing transparency being demanded by patients, investors and clinical colleagues, as well as how to ensure quality of data and reporting in all scientific communications in a fast-paced, multichannel environment.

LOCATION

National Harbor, Maryland

DATE

April 11-13, 2016

EVENT DETAILS

Innovative and Collaborative Approaches to Increase the Reach and Readership of Global Scientific Communications

This is a must-attend annual forum for Medical Communication, Medical Information, Medical Science Liaison, and Medical Writing Professionals. The cross-functional general sessions and five breakout tracks encompass all areas including medical information, medical science liaison, medical communications, medical call center, and medical writing, so you can gain further expertise and networking opportunities in your own area as well as different functional areas. Nowhere else can you network with all these professionals in one location. This content is developed to meet the needs of those who work in biopharmaceutical industry based medical scientific communications by including three central tracks covering: Medical Communications, Medical Writing: Regulatory and Publication, & Medical Science Liaisons.

LOCATION

Kissimmee, Florida

DATE

March 21-23, 2016

EVENT DETAILS

Utilize Predictive Modeling to Develop Proactive Risk Assessments and Improve Business Operations

Now in its 4th year, CBI’s highly acclaimed Compliance Monitoring Forum offers an unparalleled agenda delivered by the industry's leading experts. Don't miss the only compliance program dedicated exclusively to the complexities and nuances of building, executing and enhancing monitoring programs. Collaborate with your peers and zero in on prevailing industry approaches to advance your company’s monitoring efforts and return with clear strategies for developing and executing a first-class monitoring program.

LOCATION

PHILADELPHIA, PA

DATE

MARCH 16-17, 2016

EVENT DETAILS

Innovative and Collaborative Approaches to Increase the Reach and Readership of Global Scientific Communications

Publication planning has gone though some dramatic changes over the past few years – with even more changes on the horizon. The fate of your pub planning department hinges on its ability to adapt and innovate. TIPPA’s 15th Annual Meeting brings together a variety of players involved in the publication planning process to discuss current trends and issues facing scientific and medical communications professionals. Our renowned meetings provide a venue that promotes lively and constructive discourse on a wide range of topics across the lifecycle of a publication -- from the protocol to post-publication. This celebrated industry event tackles all of the trouble spots and problem areas you face on a daily basis including new regulations, evolving ethical standards, technological advances, and globalization. Roll up your sleeves, ask daring questions, hear innovative solutions, and walk away with tangible tools that you can apply right away in your publication planning department.

LOCATION

San Diego, California

DATE

February 29 - March 1, 2016

EVENT DETAILS

Navigate Disclosure Mandates and Data Sharing Expectations for Patient Privacy, Lay Summaries and Informed Consent

CBI’s Clinical Data Disclosure and Transparency conference is the leading platform for senior-level executives to discuss implications and approaches to stay on the forefront of the evolving disclosure and transparency landscape. Analyze perspectives from multiple stakeholders representing large and small pharmaceutical companies, regulatory agencies and academic organizations to create optimal strategies to navigate disclosure regulations and to prepare for impending clinical data sharing mandates.

LOCATION

Philadelphia, Pennsylvania

DATE

January 27-28, 2016

EVENT DETAILS

Publication Planning in Practice: Overcoming Challenges in the Age of Transparency

To be effective, medical publication professionals must stay current with the continuous evolution of guidelines and regulations, occasionally make judgment calls on ethical “grey areas,” and navigate a changing landscape while upholding good publication practices. To help members meet these challenges, this year’s meeting dispenses with the theoretical and focusses on the practical skills that drive successful publication delivery.

LOCATION

London, United Kingdom

DATE

January 19-20, 2016

2015

EVENT DETAILS

Enhance Scientific Exchange through Data Disclosure, Global Communications & Innovative Partnerships

Now in its 11th year, this conference is backed by a strong history of providing an interactive forum covering the latest developments affecting publication planning professionals. New to this year is a format that allows attendees to customize their content to reflect the most pressing issues in their role. Whether you would like more education on developing budgets, managing teams, disclosure and compliance, proving ROI or presenting to the board, this conference has the resources and collaboration to provide you with solutions. This forum enables executives of all levels to benchmark on new processes, understand changing regulations and hear perspectives from editor and author colleagues to streamline their publication process.

LOCATION

Philadelphia, Pennsylvania

DATE

December 2-3, 2015

EVENT DETAILS

Medical Communications & Information Summit

CBI’s 5th Annual Medical Communications and Information Summit delivers best practices and SOPs that are vital to the compliant, accurate and impactful delivery of medical information in the evolving healthcare landscape. Join your medical communications, medical information and medical affairs colleagues to examine the impact of changing federal regulations, optimize technology for global communication and identify compliant solutions for creating an evidence-based, transparent communication program.

LOCATION

San Francisco, California

DATE

November 16-17, 2015

EVENT DETAILS

Develop Implementation Strategies and Evaluate the Impact of the New Directive on Global Programs

In the absence of clear regulatory expectations and defined standards of practice, industry is faced with rising uncertainty of how to strategically prepare for the adoption and implementation of the new EU clinical trials regulation with minimal repercussions. With the impending regulation on the horizon, there are many questions regarding the new unified submission portal and the pending pre and post clinical trial standards requirements.

This in-depth prep forum provides practical examples and methodologies needed to put the new regulation into practice while examining its implications on global programs. Benchmark against industry trailblazers to changes that will be seen, while building actionable management strategies to successfully prepare for implementation!

LOCATION

Philadelphia, Pennsylvania

DATE

October 19-20, 2015

EVENT DETAILS

Clinical Trial Disclosure & Data Transparency

Transparency of clinical trial information is taking on new dimensions, including the release of anonymized participant-level data and return of results to study participants. Clinical trial sponsors and academia are facing a host of new registration requirements in the US and EU. Organizations, such as the Institute of Medicine, WHO, and NIH are calling on both industry and academia to share their clinical trial data. Industry’s initiatives on data sharing are also expanding. This increased transparency and use of information from clinical trials brings with it new data use opportunities and operational challenges for industry and academia.

The continuing expansion of disclosure requirements in the US and EU leave many sponsors and academia considering disclosure strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. The users of clinical trial information is varied which provides both opportunities and challenges for how the information is provided.

LOCATION

Bethesda, Maryland

DATE

September 17-18, 2015

EVENT DETAILS

Clinical Systems & Technology Marketplace

The industry’s leading innovation showcase featuring technologies that are advancing clinical R&D — is the most compelling partnering event, uniting key stakeholders charged with operationalizing clinical trials to meet the evolving demands of clinical research between sponsors, CROs, sites and patients.

LOCATION

Philadelphia, Pennsylvania

DATE

August 25-26, 2015

EVENT DETAILS

Life Sciences Product Launch Summit

Targeted Market Access Strategies in a Post-Blockbuster Era – CBI’s Product Launch Summit focuses on the changing environment of new launches, and how to adapt strategies to gain market access with new products. This conference will cover best practices for development and execution of the product launch as well as how to adapt throughout the product life cycle.

LOCATION

Philadelphia, Pennsylvania

DATE

July 28-29, 2015

EVENT DETAILS

Clinical Regulatory Medical Writing Forum

The 2nd Clinical Regulatory Medical Writing Forum equipped medical writers with the tools to compose clear, comprehensive and compliant regulatory documents and will address the impact of the 2015 European transparency requirements on medical writing operations globally. In addition, this event examined the different tools that can be used by medical writers to optimize regulatory medical writing, including structured tools for content management. More importantly, this forum addressed all the considerations for achieving high-performing medical writing teams from the early recruitment of medical writers to the efficient review of documents by various team members.

LOCATION

Philadelphia, Pennsylvania

DATE

July 15-16, 2015

EVENT DETAILS

Align Data Sharing and Results Dissemination via Registry Databases, Publications and Patient Communications

Major changes lie ahead for clinical trials regulations, EudraCT posting requirements, codes of disclosure and more. Never has CBI’s Publication and Clinical Trial Disclosure Congress been more important to the life sciences community. It is the only forum that unites publication and trial registry/disclosure professionals to share how to best coordinate results postings in registries, journals and patient communications, while remaining compliant with evolving regulatory mandates. Features include shared sessions on how to best align teams and responsibilities, customized breakout sessions more specific to your role, and tangible takehome strategies to improve internal processes and efficiencies

LOCATION

Brussels, Belgium

DATE

June 23-24, 2015

EVENT DETAILS

ISMPP Publication Planning Annual Meeting

This year's meeting, Optimizing Scientific Value: Smart and Scientific Approaches to Medical Publications, focused on the value of medical publications in contributing to scientific exchange and informing treatment decisions. The distinguished faculty offered practical solutions and examples of success in optimizing the scientific value of your publications in a “doing more with less” environment, all while upholding good publication standards and ethics.

LOCATION

Arlington, Virginia

DATE

April 27-29, 2015

EVENT DETAILS

Defining the Role of Publication Planning in an Increasingly Global, Transparent and Data-Driven World

The 14th Annual International Publication Planning Meeting brings together a variety of players involved in the publication planning process- from pub planners to medical writers to physicians & academia to medical journals- to discuss current issues surrounding pharmaceutical pub planning. Our renowned meetings provide a venue that promotes lively and constructive discourse on a wide range of issues affecting the pub planning environment. Roll up your sleeves, ask daring questions, hear innovative solutions, and walk away with tangible tools that you can apply right away in your publication planning department.

We explore ideas like: - How the Sunshine Act has changed the way pub planning departments do business - How to tackle the challenges posed by new transparency and data sharing guidelines - Which current trends in pharma are having an impact on pub planning - How to make the biggest impact with your publications in the face of time & budgeting constraints - The new role of medical journals and how they drive submissions and publications.

LOCATION

San Diego, California

DATE

February 9-10, 2015

EVENT DETAILS

Navigating Patient-Level Data Disclosure, EudraCT and International Registries

As the most comprehensive event of its kind, senior level executives convene to discuss implications of and approaches for data sharing, ensuring compliance with regulations, navigating disclosure requirements and releasing patient-level data. Ensure your organization is prepared to meet the requirements and pressures of increased disclosure and transparency of clinical trial data.

LOCATION

Philadelphia, Pennsylvania

DATE

February 5-6, 2015

EVENT DETAILS

Best Practices to Enhance TMF Collection, Monitoring, Utilization, Quality and Archiving While Remaining Compliant for Audits and Inspections

Regulators worldwide require sponsor companies to assemble a comprehensive Trial Master File during clinical trials. This means filing and maintaining hundreds of thousands of clinical documentation. This is important both for the patient and for the sponsor companies to ensure they are ready for inspection and that GCP guidance's are being followed.

In recent years, there has been much discussion regarding what documents should be included in TMF and how to make the switch to an eTMF system, which could result in greater ease of archiving for TMF professionals. While implementing eTMF can be costly and training employees can be difficult, through eTMF you can ensure real-time monitoring of data to ensure data. This will result in better management of CRO partners and ease the inspection process for sponsor companies.

TMF experts will discuss best practices for developing, managing and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF Process Owners, Quality Assurance, Clinical, Regulatory and Information Technology professionals who are responsible for TMF will share insights and best practices to facilitate successful TMF management.

LOCATION

Arlington, Virginia

DATE

January 21-23, 2015

EVENT DETAILS

Medical Publications for Better Patient Care: Integrity, Innovation, and Impact

The relatively recent shift in healthcare policy toward more active involvement of patients has sparked numerous patient-centric initiatives throughout Europe and the world. Health care professionals and policymakers have come to appreciate the value of patient partnerships in ensuring individual good health as well as the sustainability of healthcare itself.

LOCATION

London, United Kingdom

DATE

January 20-21, 2015

2014

EVENT DETAILS

Navigating Patient-Level Data Disclosure, EudraCT and International Registries

As the most comprehensive event of its kind, senior level executives convene to discuss implications of and approaches for data sharing, ensuring compliance with regulations, navigating disclosure requirements and releasing patient-level data. Ensure your organization is prepared to meet the requirements and pressures of increased disclosure and transparency of clinical trial data.

LOCATION

Philadelphia, Pennsylvania

DATE

December 11-12, 2014

EVENT DETAILS

Clinical Trial Disclosure: Towards a More Transparent World

New EU requirements are expected to come into force during 2014, impacting clinical trial processes including informed consent as well as the provision of public access to information and results of clinical trials. This workshop will review the new transparency requirements and voluntary commitments and, describe how these will impact current disclosure procedures. There will be a focus on sharing experiences on how the requirements are being implemented in practice.

The two day workshop will address the Transparency aspects of the new Clinical Trials Regulation expected to become applicable in 2016, the EMA clinical data transparency policy expected to be published in its final version for implementation later in 2014, and implementation of the clinical trials results submission to EudraCT for public disclosure via the EU Clinical Trials Register. The EU results requirements via EudraCT are to come in force by the finalization of the next version update of EudraCT, expected mid-2014. The workshop will also address how these initiatives relate to the EFPIA-PhRMA "Principles for Responsible Data Sharing"" and how industry is implementing the Principles.

An adjacent 2-day workshop on the new Clinical Trials Regulation, will offer an opportunity for attendees to focus on conceptual and practical aspects of implementation of the new Regulation. Attendees can participate in either one workshop or in the entire 3-day program. The two workshops will overlap with a day addressing the Transparency aspects of the Clinical Trials Regulation.

LOCATION

London, United Kingdom

DATE

September 23-25, 2014

EVENT DETAILS

Celebrate the Past - Invent the Future

This year marks the 50th Anniversary of the DIA Annual Meeting, the largest multidisciplinary event that brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

Provide a global unbiased platform to raise the level of discussion to facilitate innovation that will change the future of health care Provide comprehensive coverage of the full development and life cycle management of process for all health care products Offer a holistic and integrated approach to the development life cycle management of regulated health care products.

LOCATION

San Diego, California

DATE

June 15-19, 2014

EVENT DETAILS

Effectively Align the Dissemination of Study Data through Results Postings and Publications

With the more stringent focus on posting results publicly, it is a necessity that the registration process, results release, report writing and publication are aligned. As companies prepare to post study results to the EudraCT database, commit to sharing patient-level data with third party researchers and redefine publication strategies, internal teams are tasked with ensuring consistent messaging in protocols, clinical study reports, summaries, registries and publications, all while remaining compliant with changing regulations.

This is the only global life sciences congress that convenes publication planning and clinical trial disclosure professionals to share how to best coordinate results postings in registries and journals.

LOCATION

Dublin, Ireland

DATE

June 9-10, 2014

EVENT DETAILS

Leading through Collaboration

ISMPP Annual Meeting focused on the important theme of collaboration - how we can all "work smarter" together in promoting a culture of ethical practice, trust, Openness, and sharing. Collaborations within the publication planning arena were under the spotlight, as were new and innovative collaborations between Pharma and other valued partners.

LOCATION

Arlington, Virginia

DATE

April 7-9, 2014

EVENT DETAILS

13th Annual BMS IT Symposium - BITCon

The 13th Annual BMS IT Symposium ("BITCon") is expected to bring over 500 attendees for a wide range of Presentations, Discussions, Posters, Poster Presentations, Awards and Networking Activities over two days packed with activities. Over 60 current and prospective BMS supplier Exhibitors will have the opportunity to interact with BMS employees as well as meet with and learn about BMS procurement.

This event brings BMS IT professionals together to learn about projects, network with peers, and share experiences where IT enables a strategic outlook to solve business problems. Vendors are invited to bring external perspectives, best practices and examples of how companies are realizing business value through technological innovations, connectivity and ease of use. This is a global event with in-person and remote participation options to attend sessions and interact with vendors.

LOCATION

Princeton, New Jersey

DATE

March 24-25, 2014

EVENT DETAILS

Substantive Conversations on Current Operational and Compliance Challenges

This has been an exciting year in the medical publication industry, with firms mobilizing around the calls for greater transparency, responding to and operationalizing the sunshine act, and incorporating the new fourth ICMJE criterion on accountability in authorship. How are you and your firm preparing for the sea change that is emerging with respect to communicating and disseminating medical information in a complicated environment? How can you craft the message of your medical technology in a meaningful way given the onslaught of information that is newly available to doctors and patients?

TIPPA’s meetings are favorites in the field, well regarded for the high level of alchemical interaction between speakers and delegates throughout the event. Not only is the content high octane, but the rigorous and lively debate sparks new thinking and inspires innovative strategies. The intellectual curiosity and open-minded generosity of TIPPA’s participants create an event the industry highly anticipates each year

LOCATION

San Diego, California

DATE

February 10-11, 2014

EVENT DETAILS

Summit for Clinical Ops Executives

The 5th Annual SCOPE Summit gathered more than 700 industry leaders, an attendance increase of 18% from 2013, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management.

With 11 different conference tracks and two plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Recruitment and Retention, Social Media and Mobile Tech, Project Management, Forecasting, Aggregate Spend Compliance, Post-Marketing Studies, and Sample Logistics.

LOCATION

Miami, Florida

DATE

February 4-6, 2014

EVENT DETAILS

A New Era in Global Medical Publications

To be effective, medical publication professionals must stay current with the continuous evolution of guidelines and regulations, occasionally make judgment calls on ethical “grey areas,” and navigate a changing landscape while upholding good publication practices. To help members meet these challenges, this year’s meeting dispenses with the theoretical and focusses on the practical skills that drive successful publication delivery.

LOCATION

London, England

DATE

January 21-22, 2014

2013

EVENT DETAILS

Enhance scientific exchange through digital access, data disclosure and innovative partnerships

For the 9th straight year, this conference brings together leaders in medical publishing to discuss best practices for successful strategic publication planning

Understanding the demands of increased transparency
Using new technology in disseminating information
Navigating processes under a CIA
Assessing the value of publications
Integrating health outcomes into pub planning
Developing strategies for global planning

LOCATION

Philadelphia, Pennsylvania

DATE

December 9-10, 2013

EVENT DETAILS

Overcome barriers for KOL identification, access, compensation and reporting

This senior level summit focuses on the most pressing challenges facing medical affairs teams around building effective, sustainable and compliant relationships with HCPs and key opinion leaders in light of strict regulatory enforcement that is “tying the hands” of both industry professionals and healthcare providers.

Designed for advanced decision-makers and their teams, this meeting provides in-depth content to help you master the following:

Reporting headaches associated with the Sunshine Act and the intricacies of tracking and documenting data
Managing aggregate spend limits set by the company
Coordinating medical affairs and compliance teams for reporting HCP spend
Interfacing with new, non-traditional opinion leaders from private payers, physician groups and the government
Increasingly restrictive access barriers
Educating HCPs on Sunshine and FMV guidelines
HCP identification, relationship development and mapping
Innovations in engagement and advances in technological tools
Developing effective HCP advocacy in support of a strategic brand plan

LOCATION

Philadelphia, Pennsylvania

DATE

November 4-5, 2013

EVENT DETAILS

Different mechanisms for transparency, their scope, objectives, and audiences

Increased transparency changes availability and use of information from clinical trials, and brings with it new data use opportunities and operational challenges for industry and academia.

Identifying the current clinical trial disclosure requirements in the US and Europe Discussing the interrelationships between medical writing, regulatory affairs, and clinical trials disclosure teams to maintain consistency for protocol registration and results reporting Understanding the impact of greater transparency in the clinical trial disclosure environment on industry and academia Learning the advantages and implications of availability of clinical trial disclosure databases

LOCATION

Bethesda, Maryland

DATE

October 1-2, 2013

EVENT DETAILS

Deliver Impactful Information and Monitor Compliance in a Patient Empowered Era

Pharmaceutical medical affairs teams overcome unclear standards for transparency and regulatory compliance to deliver impactful scientific information CBI's Medical Communications and Information Summit delivers best practices and SOPs vital to the compliant, accurate and impactful delivery of medical information. >

Knowing the latest in CIAs and how these agreements impact HCP interactions
Understanding how litigation trends and the Sunshine Act impact medical
communications
Compliantly connecting with patients and healthcare providers through social media, apps and the web
Identifying strategies to make the most of a REMS and post-market commitments

LOCATION

San Francisco, California

DATE

September 19-20, 2013

EVENT DETAILS

DIA 2013 49th Annual Meeting

DIA 2013 49th Annual Meeting is the largest multidisciplinary event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. The events anticipates 7,000+ attendees for the largest multidisciplinary event that brings together a global network of professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

The Annual Meeting provides an invaluable forum for professionals involved in the discovery, development, and life-cycle management of pharmaceuticals, medical devices, and related products, including discussion of current and evolving areas such as comparative effectiveness research, health outcomes, and drug/device combination products.

LOCATION

Boston, Massachusetts

DATE

June 24-26, 2013

EVENT DETAILS

Streamline Internal Processes, Maintain Compliance and Increase Audience Engagement in Speaker Programs

Increased transparency changes availability and use of information from clinical trials, and brings with it new data use opportunities and operational challenges for industry and academia.

For the 11th straight year, this conference brings together leaders in medical publishing to discuss best practices for successful strategic publication planning. Transparency has never been more demanding and this conference continues to keep all publication planning teams up to speed on how their policies align with the changing external environment. Attend this conference to understand how evolving regulations, new media considerations and the global industry climate impact your publication planning initiatives.

Demands of increased transparency
Use of new technology in disseminating information
Navigating processes under a CIA
Assessing the value of publications
Integrating health outcomes into pub planning
Strategies for global planning

LOCATION

Chicago, Illinois

DATE

June 12-13, 2013

EVENT DETAILS

2nd Annual Forum on Global Publication Planning and Clinical Trial Registries Strategies for Effective and Compliant Data Disclosure and Dissemination

The EMA recently announced that companies will be required to publish their clinical trials data starting January 1, 2014, making the raw data available to third party researchers and investigators. This marks one of the biggest developments around public disclosure and sharing of data. The mandate leaves many questions – what are the implications for global competitiveness, re-analysis of data, patient confidentiality, publication and data transparency? Attend this highly anticipated forum to learn more about how professionals working in publication planning and clinical trial disclosure can coordinate data sharing to ensure transparency.

Results posting/disclosure on the EudraCT database
Posting results for unapproved drugs
The European Commission’s proposed new Clinical Trial Regulation
Evolving EudraCT and Clinicaltrials.gov regulations
The editor perspective on working with industry
Collaboration between the disclosure and medical writing groups
Emerging development of local and national registries

LOCATION

Dublin, Ireland

DATE

June 11-12, 2013

EVENT DETAILS

Empowering The Medical Publication Community To Advance The Profession

We are excited to present the program for the 9th Annual Meeting of ISMPP, Empowering the Medical Publication Community to Advance the Profession. Science is advancing daily, the way in which information is analyzed and transmitted to end-users continues to evolve, and global collaborations are ever present. Consequently, continuous examination and improvement of the standards that guide scientific and medical data dissemination are crucial.

So how do we “empower” our profession? Through education and open exchange, particularly with diverse stakeholders, including emerging markets and academia. The 9th Annual Meeting will expose you to these and other groups and equip you with the knowledge and practical tools to work globally, build better relationships and find commonalities with all stakeholder groups, as well as understand the impact of phenomena such as “Big Data,” increased data sharing between pharma and researchers and real-world data, among others.

LOCATION

Baltimore, Maryland

DATE

April 29 - May 1, 2013