Upcoming ExpertBriefing - AVELLANET - May 15, 2:00 - 3:00 PM (EDT)
Avoid 483s Under FDAAA 2007: A Cost-Effective Approach to Managing Supplier Risk
John Avellanet of Cerulean Associates LLC, presents a risk-based, cost-conscious approach to supplier selection, oversight and management. John is an an internationally acknowledged expert, speaker and syndicated author on lean regulatory compliance, preventing intellectual property theft and quality by design.
Summary:
Under the new FDAAA of 2007, the US Congress authorized the FDA to fine
individual executives $16,500 for each violation (e.g., 483 finding);
this is in addition to multi-million dollar fines levied on the corporation
as a whole. Given FDA’s stated intent to dramatically intensify
supplier scrutiny and vendor oversight, selection and qualification
of your vendors is absolutely crucial to both your quality program and
your wallet.
This webinar will reveal a successful roadmap to implement a component
of lean compliance, effectively integrating risk management and cost-effectiveness
as part of an approach to vendor selection and oversight. The webinar
will focus on how to design a strategy for lean supplier selection,
effectively share the regulatory compliance risk, and ensure consistent
vendor accountability.
Based on years of work with clients ranging from biopharmaceutical companies
and start-up medical device firms, plus his own experiences as a device
and biotech executive, Mr. Avellanet will show you how to improve your
vendor management program to improve compliance, lower cost and minimize
risk.
Components of the webinar will also discuss recent FDA expectations
toward managing vendors, suppliers and contractors, and provide insights
to achieve compliance.
What You Will Learn:
-- Effective strategy for selecting suppliers
-- Tactics to share the compliance burden and regulatory risk
-- A systematic methodology to ensure vendor accountability
-- The challenges in vendor management
-- Different categories of suppliers
-- What the FDA will be looking for when it comes to vendor management
-- Organizational considerations in implementing a vendor management
system
-- The benefits of pursuing a lean supplier strategy
Attendees will receive these free gifts:
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- Summary report of the most recent FDA Enforcement & Litigation Conference ($65 value)
- One-year subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
About the Presenter
John Avellanet, Managing Director, Cerulean Associates, LLC
John Avellanet is the co-founder and principal of the private consulting firm, Cerulean Associates LLC, and an internationally acknowledged expert, speaker and syndicated author on lean regulatory compliance, preventing intellectual property theft and quality by design.
He is also the publisher of the monthly newsletter, SMARTERCOMPLIANCE™ and the official compliance columnist for the quarterly Journal of Commercial Biotechnology.
To request access to Mr. Avellanet’s expertise, visit: www.ceruleanllc.com
Price:
LIVE audioconference - May 15, 2-3 PM EDT (includes
slides, trial subscription, CD and speaker's promotions): $399 (after
May 10 , price increases to $450)
Additional sites per company : $295
CD Only: $349
What you will receive:
— Speaker PowerPoint presentation — Free audio CD
For any questions or concerns please call 703.477.5941
Upcoming ExpertBriefing - AZEVEDO - May 20, 2:00 pm - 3:00 pm (EDT)
eCTDs -- Efficient and Affordable Approaches to Electronic Document Management
Implementing an Electronic Document Management system (EDMS) used to be millions of dollars, months if not years of customization and implementation, requiring large capital investments in software licenses and hardware, staffed by expensive and hard-to-find IT staff and consultants. Not any more. New business models are bringing low-cost, easy-to-implement solutions to market.
Antoinette Azevedo, president of e-Submissionssolutions.com, will explain the most efficient and cost-effective methods to implement an EDMS to manage your electronic drug submissions to FDA.
New viable offerings of hosted document management, open source document management, and not-for-profit services targeted at specific vertical industry document management problems are resulting in easy-to-implement, no-footprint, no capital investment solutions at very low entry-level cost.
This session will:
- Review new EDMS offerings focused on life sciences companies
- Discuss the challenges of hosted document management (SaaS deployment)
- Describe EDMS implementations to support electronic submission
publishing
- Review Microsoft Office Sharepoint Server (MOSS) as a potential
solution for life sciences companies
Background:
There is no inherent regulatory requirement for documents and data intended for submission in eCTD format to be managed by an EDMS. However, practical considerations urge the implementation of a formal EDMS including the large number of files that are collected over the lifecycle of drug/biologic research & development, the revisions those documents must go through to become final, and the legal sensitivity of the information to support a sponsor’s claims about quality, safety and efficacy.
A sponsor may in addition have a company policies concerning
compliance with FDA guidance for computer systems validation and
with 21CRF11 regulations for Electronic Records and Electronic
Signatures. It is very difficult to comply with these requirements
without the implementation of a formal, validated EDMS. Small
and early stage companies may be able to succeed using a file
server and a disciplined orderly approach to document management.
However, as employees are added, additional drugs enter the development
cycle, and studies are conducted in multiple countries, the document
management problem becomes too difficult to manage using file
servers.
Attendees will receive:
-- Free 1-year subscription to SMARTERCOMPLIANCE newsletter by Cerulean Associates
-- Free comprehensive guide to eCTD vendors by Antoinette Azevedo
-- Free comprehensive guide to EDMS vendors by Antoinette Azevedo
About the Presenter
Antoinette Azevedo
President, e-Submissionssolutions.comAntoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies -- all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.
Ms. Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through a several generations of technologies and architectures, in various industries. She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions. Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.
Price:
LIVE audioconference - May 20, 2- 3pm (EDT) (includes
slides, trial subscription, CD and speaker's promotions): $399 (after
May 15, price increases to $450)
Additional sites per company : $295
CD Only: $349
What you will receive:
— Speaker PowerPoint presentation — A Certificate of Attendance
For any questions or concerns please call 703.477.5941
Upcoming ExpertBriefing - BRADSHAW - May 28, 2:00 - 3:00 PM (EDT)
FDA Chief Counsel on FDAAA 2007: What Big Pharma Needs to Know
Presented by former FDA Chief Counsel Sheldon Bradshaw, Practice Group, Hunton & Williams, LLP
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA is the most comprehensive revision of the Federal Food, Drug and Cosmetic Act in the past 40 years.
In this presentation, former FDA Chief Counsel Sheldon Bradshaw, Partner, Hunton & Williams LLP, will highlight critical changes for the pharmaceutical industry in FDAAA 2007. This legislation has been called by CDER Deputy Director Doug Throckmorton, M.D., "perhaps the most significant regulatory change since the introduction of the FD&C Act" in 1962.
For example, under the new FDAAA of 2007, the US Congress authorized the FDA to fine individual executives $16,500 for each violation (e.g., 483 finding); this is in addition to multi-million dollar fines levied on the corporation as a whole.
Bradshaw will cover the new regulatory environment that has been created and the increased authority of the FDA, and will discuss FDA's new authority over the safety of drugs and biologics, including:
-- FDA's authority to require sponsors to conduct postapproval safety
studies and clinical trials;
-- FDA's authority to order sponsors to makes changes to a drug's
label based on new safety information; and
-- FDA's authority to order sponsors to develop a postapproval risk
evaluation and mitigation strategy (REMs) when necessary to ensure
that the benefits of the drug outweigh its risks.
Also, Mr. Bradshaw will discuss implementation issues with respect
to:
-- Direct-to-consumer (DTC) advertising;
-- Citizen petitions; and
-- Clinical trial registry and results database requirements.
He also will detail changes in the law regarding pharmacovigilance
and safety communication by FDA.
Attendees will receive these free gifts:
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- Summary report of the most recent FDA Enforcement & Litigation Conference ($65 value)
- One-year subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
About the Presenter
Sheldon Bradshaw, Partner, Hunton & Williams LLP, former FDA Chief Counsel
In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as partner and co-chair of the firm’s Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel.
As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers – on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw FDA-related litigation and reviewed and approved every regulation and guidance promulgated by the FDA and every warning letter issued by the FDA.
Price:
LIVE audioconference - May 28, 2-3 PM EDT (includes
slides, trial subscription, CD and speaker's promotions): $399 (after
May 21, price increases to $450)
Additional sites per company : $295
CD Only: $349
What you will receive:
— Speaker PowerPoint presentation — Free audio CD
For any questions or concerns please call 703.477.5941
Upcoming ExpertBriefing - CRAWLEY - RESCHEDULED - May 14, 11:00 AM - 12:00 PM (EDT)
Conducting Pediatric Clinical Trials in the European Union: The Regulatory, Scientific, and Ethics Roadmap
Back by popular request! -- Francis Crawley - Executive Director of the Good Clinical Practice Alliance
This teleconference by renowned expert Francis Crawley presents
a roadmap for effectively designing, conducting, and registering pediatric
clinical trials in the European Union (EU). It examines the current framework
for clinical trials, following on the 1996 Regulation on Medicines for
Paediatric Use, and the resulting development over the past two years
of pediatric clinical trials infrastructure in the EU: the development
of capacity within the European Medicines Agency (EMEA), the establishment
of European networks for pediatric clinical trials, and the ongoing development
of an ethical framework for pediatric research. Particular attention is
given to the role of the Paediatric Committee (PDCO) at the EMEA and the
development of a Paediatric Investigation Plan (PIP) in order to meet
EU regulatory requirements. The relationship between the current regulatory
framework and advanced modeling techniques (PK-PD modeling, first-in-children
studies, exploratory pediatric studies) are discussed.
Take away knowledge from this teleconference includes:
• The relationship between the current EU GCP framework and pediatric
clinical trials
• Similarities and differences between the US and US approaches
to paediatric drug development
• The EU legislation and guidelines for regulatory and ethical considerations
in pediatric clinical trials
• The role of the EMEA Paediatric Committee (PDCO)
• Key elements and considerations for developing a Paediatric Investigation
Plan (PIP)
• The EU’s next steps in the development of ‘Better
Medicines for Children’
Attendees will receive these free gifts:
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- Summary report of the most recent FDA Enforcement & Litigation Conference ($65 value)
- One-year subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
About the Presenter
Francis Crawley
Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, BelgiumFrancis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) Expert in ethics. He is the co-founder and Steering Committee member of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialized since 1993 in ethical, legal, and regulatory issues concerning health research, teaching at several universities in Europe and on other continents.
Since 1999 Francis is a member of the Working Group on Ethics, Union of European Medical Specialists – European Academy of Paediatrics (UEMS-EAP) [formerly CESP]. He was a member of the Steering Committee for the European Commission project ‘The Development of European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations’ (EUROSOCAP). He currently represents the GCPA partnership on the European Commission FP7 research projects: European Network for Expertise for Rare Paediatric Neurological Disorders (nEUroped) and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials (RESPECT). Francis is an Honorary Member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, United Kingdom.
Price:
LIVE audioconference - May 14, 11 am - 12 PM EDT (includes
slides, trial subscription, CD and speaker's promotions): $399 (after
May 7, price increases to $450)
Additional sites per company : $295
CD Only: $349
What you will receive:
— Speaker PowerPoint presentation — Free audio CD
For any questions or concerns please call 703.477.5941
