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PHARMACEUTICAL2 Social Media Strategies For

FDA Regulated Industries GSMI // PDF brochure

3 Quality and Compliance Training GSMI // PDF brochure

4 Packaging and Labeling - Quality Management System

GSMI // PDF brochure

5 The 5th Annual Digital Pharma™ East Conference

ExL Pharma // Pre-mailer

6 The 5th Annual Digital Pharma™ East Conference

ExL Pharma // Conference brochure

7 The 7th Annual Bio/Pharmaceutical Pricing & Reimbursement

ExL Pharma // Conference brochureConference The Digital Innovators’ Forum for Learning

Relevant Strategies and Realizing Results

Drive Dynamic Innovation Throughout the Pharmaceutical OrganizationHear Real World Examples of Digital, Social and Mobile ImpactChoose from Five Conference Streams with 85+ Remarkable Speakers

October 15-18, 2012Loews Hotel | Philadelphia, PA

Keynote SessionsSocial Networks, Viral Marketing and Big Data

Sinan Aral Professor of Informatics, Operations and Management Sciences NYU Stern & MIT

Improving Outcomes via Digital Innovation

Myrtle Potter CEO Myrtle Potter Media & Myrtle Potter and Company

Understand the Emerging Role of Gaming Technology in Healthcare

Nick DiNubile, MD Orthopaedic Surgeon & Best Selling Author DrNICK.COM

www.digitalpharmaseries.com/east

Join Over 600 of Your Digital

Marketing Peers!

ExL Pharma 10/15 - 8:51 AM 100%

Keynote Speakers For 2012

blogblog

Digital Pharma™

EastiPhone App!

App by:

The Digital Innovators’ Forum for Learning Relevant Strategies and Realizing Results


Pharma 3.0: Understand the Impact of Emerging Social and Mobile Tactics Impacting your Brands

Create a Dynamic Digital Marketing Review Process at Your Organization

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

Key Digital Themes for 2012



www.digitalpharmaseries.com/eastwww.digitalpharmaseries.com/east

Register Today! 619-810-1935

www.qualityandcompliancetraining.com

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3

3

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Institute packaging and labeling standards prior to inspection

Discuss SOP and GMP to ensure FDA compliance

�Learn best practices and controls for your packaging and labeling system

�Leverage risk with compliance to prepare yourself for the future of regulation

Keep your personnel in the know and up-to-date with FDA regulatory standards

Packaging and LabelingQuality Management

SystemApril 17-18, 2013Edison, NJ20

13

888.409.4418 | http://gsmiweb.com/training.html

Quality and ComplianCetraining in-house and public Courses for

the pharmaceutical, Biotech and medical device industries

2

Social Media Strategies For FDA Regulated Industries

Client: GSMIDescription: Conference brochure, custom infographics, icon development

8.5 x 11 electronic PDF for distribution

3

888.409.4418 | http://gsmiweb.com/training.html

Quality and ComplianCetraining in-house and public Courses for

the pharmaceutical, Biotech and medical device industries

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8 Quality and Compliance training | 888.409.4418 | http://gsmiweb.com/training.html

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

Capa process improvements

• 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

• 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

Delivery Methods Offered

Public: April 8-9, 2014 San Diego, CAIn-house/ Live onsiteE-learning Topics Covered Include

Register Today! 888.409.4418 or [email protected]

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3 Quality and Compliance training | 888.409.4418 | http://gsmiweb.com/training.html

“ Very Informative, the presenter has a lot of experience which makes the training very interesting and a great learning experience”

“ This seminar helped me understand my job. It put everything into perspective”

“ 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.”

training Clients include

* This represents a partial list of clients. Please contact for more information and a full list.

testimonials

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

Quality and Compliance Training

Client: GSMIDescription: Conference brochure, icon development

8.5 x 11, landscape, PDF for electronic distribution

4

Register Today! 619-810-1935

www.qualityandcompliancetraining.com

3

3

3

3

Institute packaging and labeling standards prior to inspection

Discuss SOP and GMP to ensure FDA compliance

�Learn best practices and controls for your packaging and labeling system

�Leverage risk with compliance to prepare yourself for the future of regulation

Keep your personnel in the know and up-to-date with FDA regulatory standards

Packaging and LabelingQuality Management

SystemApril 17-18, 2013Edison, NJ20

13

Packaging and Labeling - Quality Management System

Client: GSMIDescription: Conference brochure

8.5 x 11, PDF for electronic distribution

3 | Presented by | RegisteR today! 619-810-1935 www.qualityandcompliancetraining.com or www.gsmiweb.com

Jim has over 20 years of management experience in manufactur-ing 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 gov-ernment 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.

• overview of Pharmaceutical Packaging & Labeling

• examine cgMPs for the Manufacture, Packaging & Labeling of drug Products

• analyze the Composition and Manufacturing of drug Packaging Materials

• implement Comprehensive soPs for Packaging & Labeling

• Validate Pharmaceutical, Medical & secondary Packaging & Labeling equipment

• determine appropriate Formats & styles of Packaging & Labeling

• Comply with Legal Requirements for Labels & the Labeling Process

Assure compliance before an inspection, and prepare your organization for the future of regulation

Agenda-At-A-Glance

Jim Ingram Ingram Consulting Services

Day Two:Day One:• Comply with Bar Code Requirements

• implement safety strategies & Prevent Liability issues

• ensure Packaging & Labeling suppliers Comply with Fda Requirements

• implement Formal Quality test Procedures & Criteria

• implement Clinical Protocol Requirements for Packaged & Labeled Products

• Preparing for Fda Quality systems-Based inspection

• security Packaging & Brand Protection

Training Instructors:Bruce Cohen, PrincipalPackTechPlus, LLC


Overview of Pharmaceutical Packaging & Labeling• Identify key labeling and packaging issues in pharmaceutical R&D• 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• 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• 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• 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

Two Full Days of Packaging and Labeling System Management Training!

Agenda Day 1

Module 1

Module 2

Module 3

Module 4

Module 5

Module 6

Module 7

12

3

4

56

7

8:30 Training Begins

5:30 Training Concludes


Comply with Bar Code Requirements• 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• 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

Ensure Packaging & Labeling Suppliers Comply with FDA Requirements• 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

Implement Formal Quality Test Procedures & Criteria• 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• 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• 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

Module 8

Module 9

Module 10

Module 11

Module 12

Module 13

Module 14

89

10

1112

1314

Learn Best Practices with 14 Interactive and Comprehensive Modules

Agenda Day 2 8:30 Training Begins

5:30 Training Concludes

5

ExL Pharma 10/15 - 8:51 AM 100%

Keynote Speakers For 2012

blogblog

Digital Pharma™

EastiPhone App!

App by:



Pharma 3.0: Understand the Impact of Emerging Social and Mobile Tactics Impacting your Brands

Create a Dynamic Digital Marketing Review Process at Your Organization

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

Key Digital Themes for 2012



www.digitalpharmaseries.com/eastwww.digitalpharmaseries.com/east

ExL Pharma 10/15 - 8:51 AM 100%

Key Metrics From Digital Pharma East 2011

Jedrix Aquino Manager, Worldwide Communications ASP Matthew Barry Assistant Director HCP Multi-Channel Marketing Astellas Pharma USStacy 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 SquibbJohn Pugh Director of Digital Boehringer-Ingelheim Lisa Riedell Product Manager Sanofi-AventisJack Scannelli Director, Advertising & Promotion Review NovartisAlison Woo, Director, Social Media Bristol Myers Squibb

Sample of Confirmed Faculty To-Date:

200+ Attendees for the Mobile Day

625 Total Attendees

70+Speakers

60 Sponsors and Exhibitors

25 Case Study Presentations

4 Educational Tracks

15 Scheduled Networking Activities

Digital Pharma East Topics

of Surveyed Attendees

Would Recommend Digital Pharma to a Friend

90%

“ 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

Shwen Gwee VP of Digital Health Edelman

Mark Monseau Founder & Principal MDM Communications

ConferenceCo-Chairs:

ExL Pharma 10/15 - 8:51 AM 100%

Digital Pharma East Sponsors

Sponsors

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FOLLOW us on @DigitalPharma blogblog

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blogwww.digitalpharmaseries.com/east

The 5th Annual Digital Pharma™ East Conference

Client: ExL PharmaDescription: Conference Pre-Mailer; Direct Mail

Custom size - 7.31 x 9.5; rounded corners, 4 panel, (Digital globe image/logo provided by client)

6


Drive Dynamic Innovation Throughout the Pharmaceutical OrganizationHear Real World Examples of Digital, Social and Mobile ImpactChoose from Five Conference Streams with 85+ Remarkable Speakers


Keynote SessionsSocial Networks, Viral Marketing and Big Data


Improving Outcomes via Digital Innovation


Understand the Emerging Role of Gaming Technology in Healthcare

Nick DiNubile, MD Orthopaedic Surgeon & Best Selling Author DrNICK.COM

www.digitalpharmaseries.com/east

Join Over 600 of Your Digital

Marketing Peers!

6 Register Today! www.digitalpharmaseries.com/east • 866-207-6528 • #digpharm

Agenda At-A-Glance

WORKSHOP A9:00-11:45 AM

Building a Power Team to Drive Your Digital and Sourcing Expertise BOEHRINGER INGELHEIM

WORKSHOP B9:00-11:45 AM

Sampling in the Cloud: A Full Spectrum Analysis of the Optimal Utilization of Digital Services KNIPPER

WORKSHOP C1:00-4:00 PM

How to Design an Effective Digital Campaign With Email DMD

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 EffectivelyEmployingaUniquePay-For-PerformanceMarketingProgram:UnderstandingHowtoReachandConvertProfiled,TargetedHeartburnPatients 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

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 DigitalROCHE DIAGNOSTICS

4:45PANEL 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

4:00 Experience Mapping: Documenting the Road to Marketing SuccessBLUE DIESEL

4:45Enhance the Digital Channel and Incorporate Emerging iPad Technology To Provide Better Access to HCPsASTELLAS PHARMA US

4:00 Looking Holistically at Digital & Social Media to Drive Differentiation COGNIZANT

4:45Optimizing Sales Analytics and Metrics within a Global Digital Marketing StrategyNOVARTIS

4:00 Exploration of the Evolving World of Traditional, Digital and Pharma MarketingJANSSEN PHARMACEUTICALS & HALE ADVISORS

4:45Outsize Results on Modest Budgets: Think You Can’t Afford to do World-Class Marketing on Your Limited Budget? Think AgainHEARTBEAT IDEAS

4:00 PANEL DISCUSSION: Innovations Enhancing the Impact of Physician Engagement Activities

4:45PANEL DISCUSSION: The Role of Marketing in Improving Health Outcomes

5:30 Networking Cocktail Reception To Be Hosted By:

4:00 Networking Wine Tasting Reception To Be Hosted By:

Pre-Conference Workshop Day Monday 15th October 2012

Main Conference Day 1: Tuesday 16th October 2012

TRACK A TRACK B TRACK C TRACK D TRACK E

DIGITAL HEALTH COALITION FALL 2012 SUMMIT 1:00-4:00 PM The Industry Landscape – A Snapshot of Executive Insight For Standards & Best Practices in Digital, Social & Mobile

DIGITAL HEALTH COALITION & Selected Industry Leaders

4 Register Today! www.digitalpharmaseries.com/east • 866-207-6528 • #digpharm

General SessionsPerspectives from key industry stakeholders, guru’s and leading innovators that take place on our main conference stage.

Breakout TracksOur highly focused sessions allow you to glean valuable insights from case examples that provide instant impact on your digital marketing practices.

Workshop Master ClassesReceive executive level training in these three-hour workshops that offer a classroom feel with some personal attention on key industry topics.

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.

Unique Conference Format

October 15th Opening Day Reception4:00 PM

Hosted by:

Meet New Industry Colleagues and Reconnect with Existing Connections at the World’s Largest Pharmaceutical Marketing Event

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 experi-ence for all involved, we incorporate a series of networking breaks, special events and receptions to maximize peer-to-peer networking.

Special Events at Digital Pharma™ East:

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 [email protected]

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.

Explore and Source the best Products and Services from Industry Vendors and Partners

Unconference SessionsInspired 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.

Case StudyHear a first hand perspective on a particular instance of something used or analyzed over a period of time.

Interactive PanelsHave 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.

Power Networking

October 16th Strolling Luncheon in Exhibit Area11:45 AM

Cocktail Reception5:30 PM

Hosted by:

October 17th

Strolling Luncheon in Exhibit Area 12:45 PM

Cocktail Reception6:00 PM

Register Today! www.digitalpharmaseries.com/east | 866-207-6528 | #digpharm | 5

Who Should Attend?This conference is designed for professionals from the pharmaceutical, biotechnology and medical device industries whose responsibilities include:

• Marketing

• Digital Marketing

• Digital Strategy

• Multi-Channel Marketing

• Social Media

• New Media

• Mobile Marketing

• eMarketing

• Global Marketing

• Interactive Services

• Advertising & Promotions

• Brand Management

• Product Management

• Information Technology

• Regulatory Affairs

Digital Pharma™ East

Attendee Demographics2011

Target Audience

Title

Company Type

Attendee

Dem

ographics By Title Other

Business Development

Product/Brand Manager Director

eMarketing/Social Media/Digital Marketing

Marketing Manager/Director

ttendeeD

emographics By Company TyTT pe

Medical Device

Academic/Government

Industry Service Provider

Pharmaceutical/Biotech

43%

7%8%

6%

36%

20%

28%

10%

42%

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 reserva-tions 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.

Offering the ideal layout and amenities for our Digital Pharma™ conference audience, the Loews Philadelphia Hotel offers the following features:

• 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, state-of-the-art wellness facility

• 20 meter, two-lane heated lap pool, complete cardio center, and full-service spa

LOEWS PHILADELPHIA HOTEL1200 Market Street, Philadelphia, PA 19107

• 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

This program will also be of interest to:

Agencies, consultants, and organizations that specialize in Interactive Marketing

The 5th Annual Digital Pharma™ East Conference

Client: ExL PharmaDescription: Conference brochure; Direct mail

8.5 x 11, 20 pages, (Digital globe image/logo was provided by client)

7

The 7th Annual Bio/Pharmaceutical Pricing & Reimbursement Conference

Client: ExL PharmaDescription: Conference brochure; Direct mail

8.5 x 11, 4/4, 6 panel, tri-fold, self-mailer