Pharmaceutical Commerce - July/August 2011 - (Page 34)

Brand Marketing Communications Social Media: An Irresistible Force Colliding With an Unmovable Object < continued from page 33 Supply Chain Logistics < continued from page 22 Bard (former president of Manhattan Research), DHC brings together many leading pharma companies with Google, Epocrates (an online medium for physicians) Health Central and Digitas Health. The group is seeking to build consensus within the manufacturer community, and interact with FDA and other regulators. Bard says that the debate on behavioral tracking and digital privacy “is a major issue” to all advertisers, not just in healthcare. “There are voices out there that are saying the very premise of behavioral tracking is a bad thing. That has impact on every industry and it can also have a significant impact on the pharmaceutical industry.” However the privacy/behaviorial tracking/mobile communications discussions play out, one thing seems certain: a year from now there will be yet other new issues bubbling out of the social media mix. PC 27th, there will be two tracks of workshops, including these topics: • Implementing a pre-qualified packaging system • Variable assumed risk for ambient temperature profiles • Leasing programs for temperaturecontrolled containers • Current challenges in cold chain distribution • Training for cold chain suppliers. Codified in late 2010, Roche’s guidelines apply worldwide, and are an example of how pharma companies are grappling with the changes in communications media. The company also has a Social Media Advisory Board to address new issues. The following is excerpted from the company’s website, roche.com. I. Personal online activities 1. Be conscious about mixing your personal and business lives. There is no separation for others between your personal and your business profiles within social media. You must be aware of that. Roche respects the free speech rights of all our employees, but you must remember that patients, customers and competitors as well as colleagues may have access to the online content you post … 2. You are responsible for your actions. … Anything that brings damage to our business or reputation will ultimately be your responsibility. This does not mean that you should refrain from any activity, but that you should use common sense … 3. Follow the Roche Group Code of Conduct. When “speaking”, be compliant with the Roche Group Code of Conduct, as well as all other Roche Positions, Policies & Guidelines (i.e. Protection of Privacy, Rules on Insider Trading, etc.) … 4. Mind the global audience. Even if you are posting on a “local” platform, the information may be accessed globally. This is particularly important in our regulated business … 5. Be careful if talking about Roche. Only share publicly available information. You are not allowed to talk about the revenue, future plans, or the share price of Roche as this may have serious legal repercussions for you and the company. 6. Be transparent about your affiliation with Roche … 7. Be a “scout” for sentiment and critical issues. … If you come across positive or negative remarks about Roche or its products online that you believe are important, consider sharing them by forwarding them to your local communications department. This is most important in the case of so-called “Adverse Events”... II. Professional online activities The following principles outline what to consider when representing Roche as an official online spokesperson: 1. Follow the Roche Group Code of Conduct and Communication Policy. In the core of all communication engagements is our commitment to transparency, balanced information and equal treatment of all parties … 2. Approval processes for publications and communication. … Given the interactivity and speed of the new medium, however, it is not realistic to have each response undergo full approval by communications, legal and regulatory. Therefore, you should establish with your usual approval partners a common agreement on a bandwidth of topics and instances that may not require the normal process. … 3. Mind copyrights and give credit to the owners. 4. Use special care if talking about Roche products or financial data. Communication about the revenue, future plans, or the share price of Roche as well as statements about our products (“promotional information”) is reserved to experts in the field who have been trained to do so … 5. Identify yourself as a representative of Roche. 6. Monitor your relevant social media channels. Make sure you know what is being discussed, so that you can respond when issues arise. Have rules in place to deal with potential Adverse Event reports or potentially inappropriate or illegal content … Also, be mindful of any obligations to preserve data that may be subject to a legal hold. 7. Know and follow record management practices. … Keep records of our interactions in the online social media space. Because online conversations are often fleeting and immediate, it is important for you to keep track of them when you’re officially representing Roche. Roche’s Principles for Online Activity The main conference has three tracks, whose subject areas shift from day to day. Included are such topics as: • Cold chain packaging • Supply chain security • QA for compliant logistics • Ambient/controlled-room-temperature “think tank” • Stability testing and lifecycle management. These sessions were assembled under the guidance of industry and vendor advisory boards, including Mary Foster of US Pharmacopeia and Geoffrey Glauser of the US Dept. of Health and Human Services. Finally, the last day’s focus on CTMs includes reviews of best practices, labeling, establishing supply networks in Asia, and monoclonal antibody transportation. Throughout the conference agenda there are panel discussions bringing together specialists in air cargo; temperature-controlled ocean freight; stability testing; and others. The exhibition hall is open Sept. 28-29. Contact information for exhibitors follows, organized in four categories: air carriers; logistics services providers; tertiary packaging (and related cold storage); and instrumentation/monitoring systems. Advertisers in this issue are highlighted. PC Op-Ed FDA: Pathway to Global Product Safety and Quality < continued from page 7 admissibility of safe products and focus their investigative energies on the goods most likely to harm the public. The agency has opened additional offices in key international locations and materially increased the number of certain types of foreign inspections. Inspections of overseas drug manufacturing plants, for example, increased from 333 in 2007 to 424 in 2009. … Despite such recent improvements, FDA does not—nor will it—have the resources to adequately keep pace with the pressures of globalization. In 2008 the Government Accountability Office (GAO), recommended 34 July | August 2011 www.PharmaceuticalCommerce.com that FDA increase inspections of foreign drug establishments and improve information it receives to manage overseas inspections. But at current rates, it would take an estimated nine years for FDA to inspect every high-priority pharmaceutical facility just once. … For decades, FDA has been a recognized world leader in product safety standards. But as the agency looks to the future, it can no longer rely on the historical tools, activities and strategies to regulate products. … Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders. … The new approach rests on four core building blocks: global coalitions of regulators dedicated to building and strengthening the product safety net around the world. With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties. 2. 3. 4. 1. FDA, in close partnership with its foreign counterparts, will assemble The essence of this strategy marries creative international coalitions with cuttingedge investigative tools to continue to provide the consistently high level of safety and quality assurance the public expects—and deserves. FDA will continue to partner with other federal agencies, the states, and nations across the world. It will also look to Congress to modernize its antiquated authorities so that FDA’s legal tools keep pace with globalization. To meet these ambitious goals and achieve a true and lasting paradigm shift, FDA will engage all stakeholders in a process that will unfold over several years. Success will require boldness, creativity, and patience. It will not be easy, but it is imperative. Global supply chains, international trade, foreign sourcing, and terrorism remind us daily that the rest of the world will not stop and wait for regulators to catch up. It is incumbent upon FDA to engage its international counterparts, industry, and stakeholders worldwide to blaze the Pathway to Global Product Safety and Quality. PC http://www.roche.com http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
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