This short visual presentation contains the design work of Linda C. Modica, a NYC-Metro area art director & graphic designer. Selected published works for ExL Pharma and GSMI, conference organizers.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
The role of business process outsourcing firms during adverse events and proBarry Peters
Business process outsourcing (BPO) firms can assist pharmaceutical and medical device companies with adverse event and product quality complaints in several ways. BPOs provide trained staff to efficiently handle high call volumes during recalls or issues. They also offer customized support and expertise in regulatory reporting. Additionally, BPOs can free up company resources to focus on investigations and compliance through outsourcing routine processing tasks.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Melia Hoston seeks a position in the food service industry utilizing her background in food safety, quality management, and laboratory experience. She holds a Master's in Business Administration and Bachelor's in Biology. Her experience includes over 10 years working in quality management roles for various food companies, developing and implementing food safety systems, conducting audits, and ensuring regulatory compliance. She is proficient in Microsoft Office, laboratory equipment, and has various food safety certifications.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
Patricia Brady is a senior supply chain leader with over 20 years of experience in the biotech, pharmaceutical, medical device and diagnostics industries. She has extensive experience developing supply chain infrastructure and managing all aspects of the supply chain from sourcing and procurement to production planning, inventory management, logistics and distribution. Currently she is the Senior Manager of Supply Chain at Flexion Therapeutics where she manages their clinical supply chain network and ensures all clinical trials are completed on time.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
The role of business process outsourcing firms during adverse events and proBarry Peters
Business process outsourcing (BPO) firms can assist pharmaceutical and medical device companies with adverse event and product quality complaints in several ways. BPOs provide trained staff to efficiently handle high call volumes during recalls or issues. They also offer customized support and expertise in regulatory reporting. Additionally, BPOs can free up company resources to focus on investigations and compliance through outsourcing routine processing tasks.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Melia Hoston seeks a position in the food service industry utilizing her background in food safety, quality management, and laboratory experience. She holds a Master's in Business Administration and Bachelor's in Biology. Her experience includes over 10 years working in quality management roles for various food companies, developing and implementing food safety systems, conducting audits, and ensuring regulatory compliance. She is proficient in Microsoft Office, laboratory equipment, and has various food safety certifications.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
Patricia Brady is a senior supply chain leader with over 20 years of experience in the biotech, pharmaceutical, medical device and diagnostics industries. She has extensive experience developing supply chain infrastructure and managing all aspects of the supply chain from sourcing and procurement to production planning, inventory management, logistics and distribution. Currently she is the Senior Manager of Supply Chain at Flexion Therapeutics where she manages their clinical supply chain network and ensures all clinical trials are completed on time.
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
Mark Anthony Lewandowski has extensive experience in product development, project management, technical writing, and medical communication in the pharmaceutical industry. He has a PharmD degree and focuses on cardiovascular medicine and endocrinology. His career includes roles managing new product development, responding to medical information requests, and presenting on drug therapies.
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Mark Koeppel has over 15 years of experience in technical applications and field support roles. He has a PhD in Pharmacology and Toxicology and has trained customers on techniques like next-generation sequencing, RNA extraction, and amplification. Currently he works for HTG Molecular Diagnostics providing hands-on training, presentations, troubleshooting, and technical support to customers.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
The document discusses a presentation on applying Quality by Design (QbD) principles for biotech and specialty pharma companies. It provides an overview of the presentation's objectives, which are to provide perspective on applying QbD during development and constructing regulatory documents in parallel with development milestones. The outline discusses drivers for QbD like ICH guidelines, incentives like more efficient change control and reduced testing, and barriers like additional costs and resistance to change.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Frank Inscore has over 15 years of experience in R&D management, business development, and technical leadership. He has a PhD in Chemistry and has held positions as Director of R&D and Chief Scientist. He specializes in analytical spectroscopy, nanotechnology, and sensor development. His expertise lies in developing new products, managing cross-functional teams, and generating revenue through strategic partnerships and sales.
This document provides a summary of RJ Cook's qualifications and professional experience in quality control, quality assurance, and regulatory affairs over 28 years. It lists roles at various biotechnology companies where responsibilities included GMP quality assurance, auditing, regulatory submissions, establishing quality systems, and ensuring compliance. Key accomplishments include launching an approved drug product in Europe and establishing deviation monitoring processes.
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
The document provides an overview of process validation for pharmaceutical manufacturing. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. The objectives, types, and stages of validation are described. Key validation documentation like protocols, reports and master plans are summarized. Regulatory requirements for validation from agencies like FDA, EU, WHO and PIC/S are highlighted. The conclusion emphasizes that validation is critical for ensuring product quality and compliance.
TJM Phos Consultants is a validation consultancy based in Bangalore, India that provides regulatory services across pharmaceutical, biopharmaceutical and medical device industries. They offer expertise in equipment qualification, process validation, computer system validation, cleaning validation, analytical method validation, and commissioning and qualification. Their services also include quality systems, regulatory audits, GMP trainings, and turn-key project management and start-up support.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
Sandra Perryman has over 12 years of experience in food safety and quality assurance. She holds a Master's in Public Health and has completed certifications including SQF Lead Auditor and Preventive Controls for Human Foods Qualified Individual. She has advanced experience managing food safety programs and conducting audits for multiple companies in various food categories. Currently she is the Senior Manager of Food Safety and Quality Assurance at Atkins Nutritionals, where she oversees quality and food safety functions for over 160 products.
IT-focused Project Management in a Biopharmaceutical Manufacturing EnvironmentBruce Kozuma
This document provides an overview of project management in a biopharmaceutical manufacturing environment. It discusses the key drivers in this environment beyond typical cost, schedule, and resource constraints, including supplying product to patients and compliance with regulations. The presentation focuses on an overview of a project to support manufacturing, differing aspects of quality between PMBOK and cGMP standards, and skills for project managers to thrive in a cGMP environment.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment centerMilliporeSigma
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
G.V.S. Ratna Kumar is seeking senior level positions in production, quality, regulatory, research and development with chemical and pharmaceutical companies. He has over 20 years of experience in these areas and most recently worked as the Senior Manager of Production at Malladi Drugs and Pharmaceuticals Limited. He has extensive knowledge of quality standards, cGMP compliance, audits, documentation, and production planning.
Creating the 365 Day Long Conference and Expo 2014Chelas Poirier
The benefits of a year round event models are endless. Implementing a digital media platform with the right mix of technology, skilled personnel, consultants, vendors and “content” strategy prove extremely profitable. This approach enables the show organizer, attendees, exhibitors, sponsors, presenters and prospects to engage before, during and after a live event (including, education, operations, promotion, sales, content, data, social media, face-to-face).
Will I see you in Philadelphia next week? In case you don’t already know, I’ve been invited to speak at CBI’s Risk-Based Trial Management and Monitoring Conference.
I’m going to be sharing real world, pragmatic guidance that you can implement immediately to effectively influence your clinical trial performance.
My presentation, Practical Usage of KRIs and QTLs in Clinical Trials, will take place next Thursday, November 14th at 9:45am. I’m going to share with you:
• How to identify and close the gaps between risks and KRIs
• What the difference is between KRIs and QTLs, and how to use them effectively
• Useful examples of Centralized Monitoring findings from open data
• How to detect, combat and prevent fraud and sloppiness at an early stage
• How AI and ML advance risk-based approaches
So I can’t wait to see you at this informative and fun-filled industry expert forum,
– Artem Andrianov, CEO Cyntegrity
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
Mark Anthony Lewandowski has extensive experience in product development, project management, technical writing, and medical communication in the pharmaceutical industry. He has a PharmD degree and focuses on cardiovascular medicine and endocrinology. His career includes roles managing new product development, responding to medical information requests, and presenting on drug therapies.
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Mark Koeppel has over 15 years of experience in technical applications and field support roles. He has a PhD in Pharmacology and Toxicology and has trained customers on techniques like next-generation sequencing, RNA extraction, and amplification. Currently he works for HTG Molecular Diagnostics providing hands-on training, presentations, troubleshooting, and technical support to customers.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
The document discusses a presentation on applying Quality by Design (QbD) principles for biotech and specialty pharma companies. It provides an overview of the presentation's objectives, which are to provide perspective on applying QbD during development and constructing regulatory documents in parallel with development milestones. The outline discusses drivers for QbD like ICH guidelines, incentives like more efficient change control and reduced testing, and barriers like additional costs and resistance to change.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Frank Inscore has over 15 years of experience in R&D management, business development, and technical leadership. He has a PhD in Chemistry and has held positions as Director of R&D and Chief Scientist. He specializes in analytical spectroscopy, nanotechnology, and sensor development. His expertise lies in developing new products, managing cross-functional teams, and generating revenue through strategic partnerships and sales.
This document provides a summary of RJ Cook's qualifications and professional experience in quality control, quality assurance, and regulatory affairs over 28 years. It lists roles at various biotechnology companies where responsibilities included GMP quality assurance, auditing, regulatory submissions, establishing quality systems, and ensuring compliance. Key accomplishments include launching an approved drug product in Europe and establishing deviation monitoring processes.
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
The document provides an overview of process validation for pharmaceutical manufacturing. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. The objectives, types, and stages of validation are described. Key validation documentation like protocols, reports and master plans are summarized. Regulatory requirements for validation from agencies like FDA, EU, WHO and PIC/S are highlighted. The conclusion emphasizes that validation is critical for ensuring product quality and compliance.
TJM Phos Consultants is a validation consultancy based in Bangalore, India that provides regulatory services across pharmaceutical, biopharmaceutical and medical device industries. They offer expertise in equipment qualification, process validation, computer system validation, cleaning validation, analytical method validation, and commissioning and qualification. Their services also include quality systems, regulatory audits, GMP trainings, and turn-key project management and start-up support.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
Sandra Perryman has over 12 years of experience in food safety and quality assurance. She holds a Master's in Public Health and has completed certifications including SQF Lead Auditor and Preventive Controls for Human Foods Qualified Individual. She has advanced experience managing food safety programs and conducting audits for multiple companies in various food categories. Currently she is the Senior Manager of Food Safety and Quality Assurance at Atkins Nutritionals, where she oversees quality and food safety functions for over 160 products.
IT-focused Project Management in a Biopharmaceutical Manufacturing EnvironmentBruce Kozuma
This document provides an overview of project management in a biopharmaceutical manufacturing environment. It discusses the key drivers in this environment beyond typical cost, schedule, and resource constraints, including supplying product to patients and compliance with regulations. The presentation focuses on an overview of a project to support manufacturing, differing aspects of quality between PMBOK and cGMP standards, and skills for project managers to thrive in a cGMP environment.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment centerMilliporeSigma
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
G.V.S. Ratna Kumar is seeking senior level positions in production, quality, regulatory, research and development with chemical and pharmaceutical companies. He has over 20 years of experience in these areas and most recently worked as the Senior Manager of Production at Malladi Drugs and Pharmaceuticals Limited. He has extensive knowledge of quality standards, cGMP compliance, audits, documentation, and production planning.
Creating the 365 Day Long Conference and Expo 2014Chelas Poirier
The benefits of a year round event models are endless. Implementing a digital media platform with the right mix of technology, skilled personnel, consultants, vendors and “content” strategy prove extremely profitable. This approach enables the show organizer, attendees, exhibitors, sponsors, presenters and prospects to engage before, during and after a live event (including, education, operations, promotion, sales, content, data, social media, face-to-face).
Will I see you in Philadelphia next week? In case you don’t already know, I’ve been invited to speak at CBI’s Risk-Based Trial Management and Monitoring Conference.
I’m going to be sharing real world, pragmatic guidance that you can implement immediately to effectively influence your clinical trial performance.
My presentation, Practical Usage of KRIs and QTLs in Clinical Trials, will take place next Thursday, November 14th at 9:45am. I’m going to share with you:
• How to identify and close the gaps between risks and KRIs
• What the difference is between KRIs and QTLs, and how to use them effectively
• Useful examples of Centralized Monitoring findings from open data
• How to detect, combat and prevent fraud and sloppiness at an early stage
• How AI and ML advance risk-based approaches
So I can’t wait to see you at this informative and fun-filled industry expert forum,
– Artem Andrianov, CEO Cyntegrity
The document discusses the challenges faced by contract formulation laboratories in meeting increasing demands from pharmaceutical companies to rapidly develop new drugs while maintaining high quality and regulatory compliance standards. It outlines some of the key pressures contract labs face, including tight timelines, changing regulations, and managing resources effectively. It then provides an example of a university-affiliated contract lab, CUPSI, that enforces strict GMP training and procedures for students. The document concludes that as demands increase, contract labs need integrated quality management systems to streamline documentation, improve compliance, and reduce costs and risks.
This document summarizes a 2-day in-person seminar on documenting software for FDA submissions that will take place in San Francisco, CA. The seminar, led by Brian Shoemaker, will discuss how to reconcile agile development methods with regulatory documentation requirements. It will provide guidance on documenting requirements, design, tests, hazards, and traceability throughout development while maintaining an agile approach. Attendees will learn how to address reviews and approvals without slowing development and how to demonstrate traceability naturally. The seminar aims to show how properly applying agile principles within a quality system can satisfy regulators' expectations for well-documented products.
Charlie Sodano is an expert in reducing eDiscovery risk for pharmaceutical companies. He has over 20 years of experience managing electronic records at several major pharmaceutical companies. The webinar presentation will provide an effective strategy for pharmaceutical companies to minimize costs associated with litigation and eDiscovery through proper records management practices. It will discuss topics like record policies, litigation holds, and preserving relevant records. The webinar benefits research and development, records management, legal, IT, and validation professionals at pharmaceutical companies.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production..
Lisa Burdick has over 15 years of experience in quality and regulatory roles within ISO 13485 and FDA regulated environments. She has extensive experience with quality documentation, lot release, sterilization processes, auditing, and calibration systems. Currently she works as a Senior Quality Systems Specialist at Valeritas, where she manages lot release, sterilization processes, documentation systems, auditing, and corrective and preventative action programs.
Mark R. Jones has over 15 years of experience in operations management, including roles as an Organic Coatings Operations Manager and Engineering Manager. He has a track record of turning around struggling businesses by implementing strategic plans, lean manufacturing techniques, and quality systems. Jones' expertise includes aerospace and military specifications and regulations. He has experience developing proprietary coatings, improving production processes, and pursuing new business opportunities through marketing strategies.
The document summarizes a seminar on consumer product safety compliance plans presented by various industry trade groups. It discusses the role of trade associations in educating members on legal requirements, advocating on their behalf with regulators, and facilitating discussions on leading practices. The trade groups emphasize that compliance plans are just one part of safety programs, which also include hazard analysis, risk assessment, and product testing. They recommend establishing clear corporate safety policies, training personnel worldwide, and going beyond minimum safety standards. Recalls are seen as an opportunity to improve safety rather than an indication of failure. Technology can help with tasks like document management, data analysis, and consumer communications.
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304.
Patricia Brady is a senior supply chain leader with over 25 years of experience managing clinical and commercial supply chains in the pharmaceutical industry. She has a proven track record of successfully launching drugs in the US and EU on time. Brady is skilled in all aspects of supply chain management including strategic sourcing, supplier qualification, logistics, and ERP systems. She most recently worked as an Associate Director of Supply Chain at Flexion Therapeutics and Synageva where she helped launch new products and established key supplier relationships.
Requirements for Establishing an Effective Cleaning Validation ProgramGlobalCompliancePanel
This 2 day course will cover practical guidance on cleaning validation
regulatory compliance, in conjunction with, risk-based, reasonable and
informed decision making and activity planning. This two day
interactive course will cover fundamental principles of a cleaning
validation program, exploring such concepts as the determination of
residues to be targeted, selection of analytical and sampling methods,
determination of appropriate limits in various pharmaceutical and
biotechnology processes, and establishment of scientific rationales
acceptable to regulatory inspectors.
Scott Buchheit is seeking a regulatory specialist position in the Minneapolis-St. Paul area. He has extensive experience in medical device regulatory affairs and FDA regulated environments, including authoring technical file documents for Europe and ensuring compliance of product literature. Buchheit has a Master's in Regulatory Affairs and Services from St. Cloud State University expected in December 2015, as well as certifications in quality management. He aims to apply his regulatory strategies and submissions experience, including for 510(k)s, PMAs, and IDEs, to a new position.
The document advertises a Lean Six Sigma Green Belt certification program offered by the Terry College of Business. The 5-day program teaches the Six Sigma DMAIC methodology for process improvement and Lean tools. Students learn to define problems, collect and analyze data, and implement solutions to improve processes. The program is taught by an expert instructor with over 15 years of experience in quality engineering. Past students of Six Sigma methodology like Motorola, GE, and Honeywell reported billions of dollars in savings. The Green Belt certification prepares professionals with analytical and problem-solving skills to drive efficiencies in their organizations.
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
Webinar on how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211.
Applied statistics, with emphasis on verification, validation, and risk manag...GlobalCompliancePanel
The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
This document is a resume for Juergen Pfeiffer, detailing his experience as a quality professional over 18 years in manufacturing and automotive industries. It summarizes his roles at Mercedes-Benz and Fiat Chrysler, where he advanced supplier quality and drove PPAP activities. It also lists his education in materials science and quality management from a German university.
Sharon Roberts is a manufacturing professional with over 25 years of experience in quality assurance, safety, training, purchasing, and project management. She currently works as a PCN/PPAP Coordinator for Caterpillar, where she ensures supplier and customer part approval processes, leads audits, and trains new employees. Prior to this, she held roles in packaging, customer service, and safety training. Roberts has a bachelor's degree in organizational leadership and various certifications in quality management and safety.
Similar to PHARMACEUTICAL CONFERENCES > portfolio // Linda C. Modica (20)
Cane + Opium Furniture Pieces of DistinctionLinda Modica
Eclectic antique and reproduction furniture for sale by owner (private collection). Explore these individual , hand-selected pieces to create focal points to your well-appointed interiors.
This document summarizes Linda C. Modica's graphic design portfolio, which includes samples of her work on branding and design concepts for various events. Some of the projects in her portfolio include proposed 3D typography treatments and illustrations for an "UX" event brand, brochure designs for conferences, and an identity design for a Cannabis Business Summit that incorporates photographs and an infographic style.
A graphic design representation for the love of one wonderful and special, but naughty male iguana named Paco. Graphic design elements include a venn diagram, dimensional pie chart (info graphic), mock-advert, mock propaganda poster design, mock instagram and pinterest design.
Identity creation and graphic design for Cannabis Conferences in Denver, Colorado and New York, New York. Brochures, signage, truss coverage, sponsor passport, tote bags and post cards.
Investment Banking & Financial Corporate Brand & Identity // Linda C. ModicaLinda Modica
Select brand and identity projects for a New York City-based consulting firm that specializes in structured finance, investment banking and investment management.
Social Media Infographics & Editorial Design / Linda C. ModicaLinda Modica
This document appears to be a graphic designer's portfolio highlighting their work designing materials for Social Media Strategies Summits (SMSS) conferences from 2015-2017. It includes brochures, infographics, and interior pages designed for SMSS conferences in New York City, Chicago, and Las Vegas. The designs were for conference brochures, sponsorship guides, and other promotional materials. The portfolio aims to showcase the designer's skills in conference collateral, graphic design, and editorial design for social media marketing events.
SOCIAL MEDIA // DIGITAL & MOBILE MARKETING > portfolio // Linda C. ModicaLinda Modica
This short visual presentation contains the design work of Linda C. Modica, a NYC-Metro area art director & graphic designer. Selected published works for GSMI, a west-coast based conference organizer.
BUSINESS CARDS > portfolio // Linda C. ModicaLinda Modica
This short visual presentation contains the design work of Linda C. Modica, a NYC-Metro area art director & graphic designer. Selected business cards from the financial, conference, Japanese tourism and children's book industries.
SMALL // MEDIUM BUSINESS + NON-PROFIT > portfolio // Linda C. ModicaLinda Modica
This short visual presentation contains the design work of Linda C. Modica, a NYC-Metro area art director & graphic designer. Selected published work for the Graphic Artists Guild of New York, Selina Alko author & illustrator and Shinkageryu Hyoho Kenjutsu studio.
FINANCIAL & CORPORATE COLLATERAL > portfolio // Linda C. ModicaLinda Modica
This short visual presentation contains the design work of Linda C. Modica, a NYC-Metro area art director & graphic designer. Selected published works for GSMI, IMN (Information Management Network) and Black Swan Consulting Group.
Maximize Your Content with Beautiful Assets : Content & Asset for Landing Page pmgdscunsri
Figma is a cloud-based design tool widely used by designers for prototyping, UI/UX design, and real-time collaboration. With features such as precision pen tools, grid system, and reusable components, Figma makes it easy for teams to work together on design projects. Its flexibility and accessibility make Figma a top choice in the digital age.
International Upcycling Research Network advisory board meeting 4Kyungeun Sung
Slides used for the International Upcycling Research Network advisory board 4 (last one). The project is based at De Montfort University in Leicester, UK, and funded by the Arts and Humanities Research Council.
EASY TUTORIAL OF HOW TO USE CAPCUT BY: FEBLESS HERNANEFebless Hernane
CapCut is an easy-to-use video editing app perfect for beginners. To start, download and open CapCut on your phone. Tap "New Project" and select the videos or photos you want to edit. You can trim clips by dragging the edges, add text by tapping "Text," and include music by selecting "Audio." Enhance your video with filters and effects from the "Effects" menu. When you're happy with your video, tap the export button to save and share it. CapCut makes video editing simple and fun for everyone!
Architectural and constructions management experience since 2003 including 18 years located in UAE.
Coordinate and oversee all technical activities relating to architectural and construction projects,
including directing the design team, reviewing drafts and computer models, and approving design
changes.
Organize and typically develop, and review building plans, ensuring that a project meets all safety and
environmental standards.
Prepare feasibility studies, construction contracts, and tender documents with specifications and
tender analyses.
Consulting with clients, work on formulating equipment and labor cost estimates, ensuring a project
meets environmental, safety, structural, zoning, and aesthetic standards.
Monitoring the progress of a project to assess whether or not it is in compliance with building plans
and project deadlines.
Attention to detail, exceptional time management, and strong problem-solving and communication
skills are required for this role.
ARENA - Young adults in the workplace (Knight Moves).pdfKnight Moves
Presentations of Bavo Raeymaekers (Project lead youth unemployment at the City of Antwerp), Suzan Martens (Service designer at Knight Moves) and Adriaan De Keersmaeker (Community manager at Talk to C)
during the 'Arena • Young adults in the workplace' conference hosted by Knight Moves.
Fonts play a crucial role in both User Interface (UI) and User Experience (UX) design. They affect readability, accessibility, aesthetics, and overall user perception.
PHARMACEUTICAL CONFERENCES > portfolio // Linda C. Modica
1. Labeling
2013
Quality and
ComplianCe
training
PHARMA
CEUTICAL
3
Quality and Compliance Training
// PDF brochure
GSMI
FDA Regulated Industries
// PDF brochure
GSMI
5 The 5th Annual Digital Pharma™
East Conference
ExL Pharma // Pre-mailer
6 The 5th Annual Digital Pharma™
East Conference
ExL Pharma // Conference brochure
in-house and public Cour
the pharmaceutical, Biot
medical device industrie
888.409.4418
| http://gsmiweb.co
10/15 - 8:51 AM
ExL Pharma
graphic design // conferences
2 Social Media Strategies For
April 17-18, 2013
Edison, NJ
100%
October 15-18, 2012
Loews Hotel | Philadelphia, PA
The Digital Innovators’ Forum for Learning
Relevant Strategies and Realizing Results
Keynote Speakers For 2012
Myrtle Potter
CEO
Myrtle Potter Media
Myrtle Potter and Company
4 Packaging and Labeling -
Sinan Aral
Professor of Informatics,
Operations and
Management Sciences
NYU Stern MIT
Quality Management System
Digital
// PDF brochure
GSMI
Pharma™
Key Digital Themes for 2012
600
7 The 7th Annual Bio/Pharmaceutical
Create a Dynamic Digital Marketing Review Process at
Your Organization
East
Join Over
of Your Digital
Marketing Peers!
iPhone App!
App by:
Pricing Reimbursement Conference
ExL Pharma // Conference brochure
Pharma 3.0: Understand the Impact of Emerging Social
October 15-18,
and Mobile Tactics Impacting your Brands
2012
Loews Hotel | Philadelphia, PA
Understand the Impact and Trends Around mHealth
The Digital Innovators’ Forum for Learning
Results
Embrace and Leverage BIG DATA Analytics at
Relevant
your OrganizationStrategies and Realizing
Stay Up to Date with FDA Social Media Guidance
Successfully Integrate the iPad throughout the Enterprise
Drive Dynamic Innovation Throughout the Pharmaceutical Organization
Choose from Five Conference Streams with 85+ Remarkable Speakers
Linda C. Modica
Art Director | Brand Specialist | Graphic Designer
Keynote Sessions
blog
tsae/moc.seiresamrahplatigid.www
portfolio
www.digitalpharmaseries.com/east
golb
Hear Real World Examples of Digital, Social and Mobile Impact
Improving Outcomes
via Digital Innovation
Social Networks, Viral
Marketing and Big Data
Understand the Emerging Role of
Gaming Technology in Healthcare
Myrtle Potter
CEO
Myrtle Potter Media
Myrtle Potter and Company
Sinan Aral
Professor of Informatics,
Operations and Management Sciences
NYU Stern MIT
Nick DiNubile, MD
Orthopaedic Surgeon
Best Selling Author
DrNICK.COM
www.digitalpharmaseries.com/east
2. Social Media Strategies For FDA Regulated Industries
Client: GSMI
Description: onference brochure, custom infographics, icon development
C
8.5 x 11 electronic PDF for distribution
2
3. Quality and
ComplianCe
training
in-house and public Courses for
the pharmaceutical, Biotech and
medical device industries
Quality and Compliance Training
Client: GSMI
Description: onference brochure, icon development
C
8.5 x 11, landscape, PDF for electronic distribution
•
•
•
•
•
•
• Record change control methods for your CAPA process
• Address incidents in a timely manner with a process
oriented timeline
• Identify the impact of nonconformance, and mitigate the
risk appropriately
• Manage escalation
• Verify and validate incidents
Register Today!
888.409.4418 or B.zvaifler@gsmiweb.com
3
8
Quality and Compliance training
|
888.409.4418
|
http://gsmiweb.com/training.html
“Excellent training, even for someone who
has been in the industry for a number of
years.”
“The training was relevant. The quality of
the program was excellent.”
“This course and instructor, was one of the
most insightful and applicable QA courses
that I have taken.”
“I’m very pleased– it was time well spent.
I feel inspired and empowered
to design and implement a program
for my company.”
* This represents a partial list of clients. Please contact for more information and a full list.
3
Quality and Compliance training
|
888.409.4418
|
http://gsmiweb.com/training.html
past Clients
DRA Compliance
Manager, Novartis
QA Specialist
Allergy Labs
Sr. Director,
Bayer Advanced
QA Manager,
Millennium Labs
QS Manager,
Millennium Labs
General Counsel,
Onyx Pharmaceuticals, Inc
instructors
Analyze FDA CAPA Requirements
Develop a comprehensive CAPA process
CAPA Data Collection
Avoid multiple investigations
Validating CAPA processes
Increase ROI by decreasing penalties
and costs associated with incidents
Learn to test potential cause and effect
Mitigate risk effectively
Differentiate between corrections, corrective
action and preventative action
Conduct quality root cause analysis and
failure investigations
Document CAPA report effectively
Measure the effectiveness of a CAPA process
“This seminar helped me understand my
job. It put everything into perspective”
Course outlines
•
•
•
•
•
•
“Very Informative, the presenter has a lot
of experience which makes the training
very interesting and a great learning
experience”
Contact
Topics Covered Include
past Clients
This course will review the requirements of a lean and effective CAPA system. CAPA processes are continuously
cited in warning letters and 483s, this course will mitigate your risk of nonconformance by reviewing the
necessary components of a CAPA process as well as looking at best practices for an effective system
testimonials
instructors
Public:
April 8-9, 2014
San Diego, CA
In-house/ Live onsite
E-learning
Contact
Delivery Methods Offered
training Clients
include
Course outlines
Capa process improvements
gSmi training
overview
| http://gsmiweb.com/training.html
gSmi training
overview
888.409.4418
4. Assure compliance
before an inspection, and
prepare your organization for the
future of regulation
Training Instructors:
Jim Ingram
Bruce Cohen, Principal
Ingram Consulting Services
2013
Packaging and
Labeling Quality Management
System
April 17-18, 2013
Edison, NJ
PackTechPlus, LLC
Jim has over 20 years of management experience in manufacturing and packaging of pharmaceutical, food and cosmetic products,
including over 10 years with glaxosmithKline. throughout his
career, he has had direct responsibility for compliance with government agencies such as Fda, ePa, dea and da. over the past
15 years as an independent consultant, Jim has developed a range
of processes and training programs, resulting in improved Fda
audits and relief from Consent decrees.
Jim received his associates degree in engineering from Central
Carolina technical College and attended Campbell University
Business school. He has numerous patents to his credit and is
a Certified Packaging Professional with the Institute of Packaging
Professionals.
Bruce has been an innovative leader in pharmaceutical
packaging for over 35 years. He has held positions at alcon
Laboratories, BBL, Boehringer Mannheim diagnostics, sterling
drug inc., glaxo inc. and glaxosmithKline. Currently, he is
owner/Principal of PacktechPlus, LLC, a packaging technology
consulting firm.
Bruce’s expertise includes packaging materials, primary and
secondary packaging process equipment, labeling/graphics
design process and equipment, serialization, and over 25 years
of anti-counterfeiting strategy and tactical process design.
He is a member and past chairman of the drug Pharmaceutical
Packaging Committee of ioPP, past chairman of the PhRMa Bar
Code technical Committee and the PhRMa Paperless Labeling
task Force.
Agenda-At-A-Glance
Day One:
Day Two:
• overview of Pharmaceutical Packaging Labeling
• Comply with Bar Code Requirements
• examine cgMPs for the Manufacture, Packaging Labeling
of drug Products
• implement safety strategies Prevent Liability issues
• analyze the Composition and Manufacturing of drug
Packaging Materials
• implement Comprehensive soPs for Packaging Labeling
• ensure Packaging Labeling suppliers Comply with
Fda Requirements
• implement Formal Quality test Procedures Criteria
• Validate Pharmaceutical, Medical secondary Packaging
Labeling equipment
• implement Clinical Protocol Requirements for
Packaged Labeled Products
• determine appropriate Formats styles of Packaging Labeling
• Preparing for Fda Quality systems-Based inspection
• Comply with Legal Requirements for Labels the Labeling Process
• security Packaging Brand Protection
3 | Presented by
| RegisteR today!
619-810-1935 www.qualityandcompliancetraining.com or www.gsmiweb.com
Keep your personnel in the know and
up-to-date with FDA regulatory standards
Packaging and Labeling - Quality Management System
packaging and
3 Institute standards prior to
labeling
Client: GSMI
inspection
3
Description: Conference brochure
8.5 x 11, PDF for electronic distribution
Discuss SOP and GMP to
ensure FDA compliance
3 Learn best practices and
controls for your packaging
and labeling system
3 Leverage risk with compliance
to prepare yourself for the
Two Full Days of Packaging
and Labeling System Management
Training!
future of regulation
Agenda
8:30
Register Today!
1
2
619-810-1935
www.qualityandcompliancetraining.com
4
3
Module 3
4
Module 4
5
6
7
8:30
• Identify key labeling and packaging issues in pharmaceutical RD
• Analyze labeling and packaging development processes, including marketing aspects
• Outline roles and responsibilities of development team
Examine cGMPs for the Manufacture, Packaging Labeling of Drug Products
Module 2
•
•
•
•
Review the FDA drug approval process and general packaging/labeling guidelines
Discuss the impact of current Good Manufacturing Practices (cGMPs)
Analyze USP test procedures and requirements
Explore the FDA’s recently proposed rule for prescription drug labeling
Analyze the Composition and Manufacturing of Drug Packaging Materials
•
•
•
•
Identify types of glass used in manufacturing and drug packaging
Explore the use of metal in tin plates
Inspect the nature of plastics and composite films
Examine the chemical structure of elastomeric material
Implement Comprehensive SOPs for Packaging Labeling
•
•
•
•
Ensure written procedures include set-up of packaging equipment
Decide what measures should be taken when process AQL limits are exceeded
Determine precise packaging plans and label control
Specify documentation and personnel involvement
Validate Pharmaceutical, Medical Secondary Packaging Labeling Equipment
Module 5
• Review common challenges associated with equipment
• Discuss typical pitfalls associated with Form-Fill-Seal machines
• Validate air handling systems in packaging rooms and aseptic processing equipment
Determine Appropriate Formats Styles of Packaging Labeling
Module 6
Module 7
5:30
4 | Presented by
Agenda
Day 1
Training Begins
Overview of Pharmaceutical Packaging Labeling
Module 1
Learn Best Practices with
14 Interactive and
Comprehensive Modules
•
•
•
•
Examine ease of use, legibility, understandability
Assess aesthetic properties analyze barrier properties
Explore current security features
Ensure sufficient use layout of print warnings
Comply with Legal Requirements for Labels the Labeling Process
• Identify legal issues related to repackaging relabeling
• Report drug product problems appropriately
Training Concludes
| RegisteR today!
8
9
Comply with Bar Code Requirements
Module 8
• Define FDA’s expectations regarding bar codes for human drug products
• Identify solutions to technical challenges raised by bar code requirements
• Implement strategies to achieve maintain compliance
Implement Safety Strategies Prevent Liability Issues
Module 9
•
•
•
•
•
•
Explain the liability issues associated with labeling
Analyze the impact of direct-to-consumer (DTC) advertising
Ensure that clinical study safety information is incorporated on package inserts
Include post-marketing and Phase IV study data in package inserts
Incorporate conversion of terminology for safety information
Ensure accurate distinct labeling prevent mislabeling
10
Ensure Packaging Labeling Suppliers Comply with FDA Requirements
11
12
Implement Formal Quality Test Procedures Criteria
Module 10
13
14
Module 11
•
•
•
•
•
Establish metrics to evaluate an outsource provider
Conduct an efficient pre-qualification process
Determine responsibilities of suppliers vendors
Ensure compliance with test requirements
Establish the role of the QA group
• Validate testing data for product shelf life
• Ensure the package protects the product
• Implement techniques for changes in batch size
• Examine trending data
Implement Clinical Protocol Requirements for Packaged Labeled Products
Module 12
•
•
•
•
•
Prepare for the manufacture of clinical trial material
Examine the manufacturing techniques for various drug product types
Analyze storage labeling dispensing
Evaluate label control and packaging plans
Ensure compliance with test requirements
Preparing for FDA Quality Systems-Based Inspection
Module 13
Module 14
5:30
619-810-1935 www.qualityandcompliancetraining.com or www.gsmiweb.com
Day 2
Training Begins
5 | Presented by
• Review cGMPs that affect clinical supply manufacturing
• Ensure proper documentation
• Review training process for SOPs
• Review impact of OOS on packaging labeling
Security Packaging Brand Protection
• Review counterfeit issues and the impact it has on your products
• Review examples of different counterfeits what you can do to protect your brand
Training Concludes
| RegisteR today!
619-810-1935 www.qualityandcompliancetraining.com or www.gsmiweb.com
5. 10/15 - 8:51 AM
ExL Pharma
100%
October 15-18, 2012
Loews Hotel | Philadelphia, PA
The Digital Innovators’ Forum for Learning
Relevant Strategies and Realizing Results
Keynote Speakers For 2012
10/15 - 8:51 AM
ExL Pharma
100%
10/15 - 8:51 AM
ExL Pharma
Digital Pharma East Topics
Myrtle Potter
CEO
Myrtle Potter Media
Myrtle Potter and Company
Sinan Aral
Professor of Informatics,
Operations and
Management Sciences
NYU Stern MIT
Key Digital Themes for 2012
Digital
Pharma™
Pharma 3.0: Understand the Impact of Emerging Social
and Mobile Tactics Impacting your Brands
East
Create a Dynamic Digital Marketing Review Process at
Your Organization
iPhone App!
App by:
Understand the Impact and Trends Around mHealth
Embrace and Leverage BIG DATA Analytics at
your Organization
Stay Up to Date with FDA Social Media Guidance
Successfully Integrate the iPad throughout the Enterprise
blog
golb
www.digitalpharmaseries.com/east
Key Metrics From Digital Pharma East 2011
Sponsors
625
Surveyed
90%ofAttendees 70+
Total Attendees
Would Recommend
Digital Pharma to a Friend
Speakers
Sponsors and
Exhibitors
25
4
15
200+
Case Study
Presentations
Educational Tracks
Scheduled
Networking Activities
Attendees for
the Mobile Day
Conference
Co-Chairs:
Shwen Gwee
VP of Digital Health
Edelman
60
Mark Monseau
Founder Principal
MDM Communications
Sample of Confirmed Faculty To-Date:
Jedrix Aquino
Manager, Worldwide
Communications
ASP
Matthew Barry
Assistant Director
HCP Multi-Channel Marketing
Astellas Pharma US
Stacy Burch
Director, Corporate Reputation
and Digital Communications
Sanofi-Aventis
Jeffrey Daniels
Patient Recruitment Specialist
Celldex Therapeutics Inc.
Peter Dannenfelser
Director, Pharmaceutical Digital
Marketing North America
Johnson Johnson
Carlos Dortrait
Product Director
Janssen Biotech
Doug Elwood
Director, Global Medical
Information Communications
Innovation
Bristol Myers Squibb
Uri Goren
Spokesman and PR Manager
NeoPharm
Tony Jewell
Senior Director
Corporate Communications
AstraZeneca
Harold Johns
Manager, Global Web Solutions
Johnson Johnson
Cynthia North
Customer Marketing Director
Bayer Corporation
Nancy Phelan
Vice President, Customer Strategy
Bristol Myers Squibb
John Pugh
Director of Digital
Boehringer-Ingelheim
Lisa Riedell
Product Manager
Sanofi-Aventis
Jack Scannelli
Director, Advertising
Promotion Review
Novartis
Alison Woo,
Director, Social Media
Bristol Myers Squibb
tsae/moc.seiresamrahplatigid.www
“Digital Pharma East was truly a meeting place for Pharma Marketing Thought
Leaders to share ideas and experiences. I am sure everyone learned at least one
thing they did not know before or, met a vendor or a colleague that can help them
move their digital marketing efforts forward.”
-Director, Mobile and Social Media, ASTRAZENECA
The 5th Annual Digital Pharma™ East Conference
Client:
5
100%
Digital Pharma East Sponsors
ExL Pharma
Description: onference Pre-Mailer; Direct Mail
C
Custom size - 7.31 x 9.5; rounded corners, 4 panel, (Digital globe image/logo provided by client)
®
Join The Conversation!
LIKE our Page
blog
Subscribe to our Digital Pharma
blogblog
Newsletter at www.exlpharma.com
FOLLOW us on
blog
@DigitalPharma
Digital Pharma Blog
digitalblog.exlpharma.com
www.digitalpharmaseries.com/east
blog
6. Unique Conference Format
Who Should Attend?
This conference is designed for professionals from the pharmaceutical, biotechnology
and medical device industries whose responsibilities include:
Digital Pharma™ East provides a unique blend of learning formats giving you access to a number
of different types of content delivery to choose from. We provide you the ability to tailor your
agenda and choose session formats that work best based on your objectives.
General Sessions
Perspectives from key industry stakeholders, guru’s
and leading innovators that take place on our main
conference stage.
Breakout Tracks
Workshop Master Classes
• Social Media
• Interactive Services
• Regulatory Affairs
Case Study
7%
Hear a first hand perspective on a particular instance
of something used or analyzed over a period of time.
Target
Interactive Panels
Have the opportunity to listen to group discussion
and debate from a myriad of industry perspectives
on the hottest issues and have your burning
questions addressed.
Audience
8%
Medical Device
Academic/Government
Industry Service Provider
Company
Type
42%
yC
om
p
Pharmaceutical/Biotech
any
Typ
Attendee Demographics
2011
Meet New Industry Colleagues and
Reconnect with Existing Connections
at the World’s Largest Pharmaceutical
Marketing Event
Agencies, consultants, and organizations
that specialize in Interactive Marketing
43%
Digital Pharma™ East
e
6%
Marketing Manager/Director
10%
36%
Attendee D
Networking
• Information Technology
B
Power
• Product Management
• Global Marketing
ics
ph
gra
Receive executive level training in these three-hour
workshops that offer a classroom feel with some
personal attention on key industry topics.
• Brand Management
• eMarketing
• Multi-Channel Marketing
This program will also
be of interest to:
• Advertising Promotions
• Mobile Marketing
• Digital Strategy
Inspired by the spirit of social media, these interactive
sessions provide attendees the opportunity to
communicate with their peers in group discussions that
push the boundaries of traditional conference formats.
• New Media
• Digital Marketing
ttendee Demo
Our highly focused sessions allow you to glean
valuable insights from case examples that provide
instant impact on your digital marketing practices.
• Marketing
Unconference Sessions
cs
By
Title
Product/Brand Manager Director
28%
hi
rap
og
em
When you ask anyone who has attended Digital Pharma™ in the past, they always tell you it is the best digital event to be at in terms of
education and networking. In addition to four days of cutting edge content, we provide unparalleled networking opportunities that allow
you the time and ability to meet other innovators in this industry and form connections that make a difference. To maximize the experience for all involved, we incorporate a series of networking breaks, special events and receptions to maximize peer-to-peer networking.
eMarketing/Social Media/
Digital Marketing
Business Development
Tit
le
20%
Other
Special Events at Digital Pharma™ East:
October 15th
October 16th
October 17th
4:00 PM
11:45 AM
12:45 PM
Opening Day Reception
Hosted by:
Join Over 600
of Your Digital
Marketing Peers!
Cocktail Reception
5:30 PM
October 15-18, 2012
Loews Hotel | Philadelphia, PA
Strolling Luncheon in Exhibit Area
LOEWS PHILADELPHIA HOTEL
Strolling Luncheon in Exhibit Area
1200 Market Street, Philadelphia, PA 19107
To make hotel reservations attendees can call the Loews reservations department at 888-575-6397 and request
the negotiated rate for ExL’s 6th Digital Pharma™ East. You may also use the following weblink to make reservations online: http://www.loewshotels.com/en/Philadelphia-Hotel/GroupPages/18O101812. The group rate is
available until September 24, 2012. Please book your room early as rooms available at this rate are limited.
Cocktail Reception
6:00 PM
Hosted by:
Offering the ideal layout and amenities for our Digital Pharma™ conference audience, the Loews Philadelphia
Hotel offers the following features:
In addition, there will be several private, invite only breakfast, lunch and
dinner meetings that you will be informed of after registering for the conference.
• 581 guest rooms, including 44 concierge club rooms
and 14 specialty suites with magnificent views of the
Philadelphia skyline
• Breathe Spa and Fitness: a 15,000-square-foot, stateof-the-art wellness facility
• 20 meter, two-lane heated lap pool, complete cardio
center, and full-service spa
If you are interested in hosting a cocktail reception or a breakfast, lunch or dinner meeting, please contact
Jayson Mercado at 212-400-6236 or by e-mail at jmercado@exlpharma.com
The Digital Innovators’ Forum for Learning
Relevant Strategies and Realizing Results
Explore and Source the best Products and Services from Industry Vendors and Partners
4
Register Today! www.digitalpharmaseries.com/east | 866-207-6528 | #digpharm | 5
Register Today! www.digitalpharmaseries.com/east • 866-207-6528 • #digpharm
Drive Dynamic Innovation Throughout the Pharmaceutical Organization
Hear Real World Examples of Digital, Social and Mobile Impact
Agenda
Choose from Five Conference Streams with 85+ Remarkable Speakers
Keynote Sessions
Improving Outcomes
via Digital Innovation
Social Networks, Viral
Marketing and Big Data
Sinan Aral
Professor of Informatics,
Operations and Management Sciences
NYU Stern MIT
Nick DiNubile, MD
Orthopaedic Surgeon
Best Selling Author
DrNICK.COM
At-A-Glance
Understand the Emerging Role of
Gaming Technology in Healthcare
Myrtle Potter
CEO
Myrtle Potter Media
Myrtle Potter and Company
www.digitalpharmaseries.com/east
Pre-Conference Workshop Day
Monday 15th October 2012
WORKSHOP A
WORKSHOP B
WORKSHOP C
DIGITAL HEALTH COALITION
9:00-11:45 AM
9:00-11:45 AM
1:00-4:00 PM
Building a Power Team to Drive
Your Digital and Sourcing
Expertise
BOEHRINGER INGELHEIM
Sampling in the Cloud: A Full
Spectrum Analysis of the Optimal
Utilization of Digital Services
KNIPPER
How to Design an Effective
Digital Campaign With Email
DMD
FALL 2012 SUMMIT 1:00-4:00 PM
The Industry Landscape – A Snapshot of Executive
Insight For Standards Best Practices in Digital, Social
Mobile
4:00
DIGITAL HEALTH COALITION Selected Industry Leaders
Networking Wine Tasting Reception To Be Hosted By:
Main Conference
Day 1: Tuesday 16th October 2012
08:30
Co-Chairmen’s Welcome
08:40
KEYNOTE: Improving Diabetes Outcomes via Digital Innovation MYRTLE POTTER MEDIA, INC.
09:20
Future 15 Pharma Trends KLICK HEALTH
10:00
Networking Refreshment Break
10:30
Digital Engagement and Customer Centricity BRISTOL-MYERS SQUIBB
11:10
KEYNOTE: Social Networks,Viral Marketing and Big Data – Distinguishing Hope from Hype With Science NYU STERN MIT
11:45
Luncheon
1:00
Effectively Employing a Unique Pay-For-Performance Marketing Program: Understanding How to Reach and Convert Profiled, Targeted Heartburn Patients
QUALITY HEALTH TAKEDA PHARMACEUTICALS
1:40
PANEL DISCUSSION: Driving Innovation in our “Slow-Moving-Ultra-Conservative” World of Pharma: Closing the Gap Between Knowing and Doing
2:30
Developing a Culture of Communication and Alignment Between Marketing and IT Divisions to Achieve Optimal Results MAQUET
3:30
Networking Refreshment Break
TRACK A
The 5th Annual Digital Pharma™ East Conference
Client:
6
ExL Pharma
Description: onference brochure; Direct mail
C
8.5 x 11, 20 pages, (Digital globe image/logo was provided by client)
TRACK B
TRACK C
TRACK D
TRACK E
Patient Consumer
Marketing
Healthcare Practitioner
Marketing
Internal Process
Improvement Analytics
Multi-Channel Marketing
Strategy
Interactive
Unconference Sessions
4:00
Using Data to Shift the
Marketing Mix and Budget
Allocation to Digital
ROCHE DIAGNOSTICS
4:00
Experience Mapping:
Documenting the Road to
Marketing Success
BLUE DIESEL
4:00
Looking Holistically at
Digital Social Media to
Drive Differentiation
COGNIZANT
4:00
Exploration of the Evolving
World of Traditional, Digital
and Pharma Marketing
JANSSEN PHARMACEUTICALS
HALE ADVISORS
4:00
PANEL DISCUSSION:
Innovations Enhancing the
Impact of Physician Engagement
Activities
4:45
PANEL DISCUSSION: Health
Literacy in the Digital World:
How to Develop Health
Initiatives so Patients Can not
Only Read, But Understand,
and Act on the Information
4:45
Enhance the Digital Channel
and Incorporate Emerging iPad
Technology To Provide Better
Access to HCPs
ASTELLAS PHARMA US
4:45
Optimizing Sales Analytics and
Metrics within a Global Digital
Marketing Strategy
NOVARTIS
4:45
Outsize Results on Modest
Budgets: Think You Can’t Afford
to do World-Class Marketing
on Your Limited Budget?
Think Again
HEARTBEAT IDEAS
4:45
PANEL DISCUSSION:
The Role of Marketing in
Improving Health Outcomes
5:30
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• Business Center and full-service audio visuals
• Full-service Concierge
• 10 minutes from Amtrak 30th Street Station
• Across the street from SEPTA Market East
Regional Rail Station
• 20 minutes from Philadelphia Airport
• 42,000 square feet of flexible function space
Networking Cocktail Reception To Be Hosted By:
Register Today! www.digitalpharmaseries.com/east • 866-207-6528 • #digpharm
7. The 7th Annual Bio/Pharmaceutical Pricing Reimbursement Conference
Client:
ExL Pharma
Description: onference brochure; Direct mail
C
8.5 x 11, 4/4, 6 panel, tri-fold, self-mailer
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