International Pharmaceutical Manufacturing and Distribution -2016April 25-26,2016 Ambassador Plaza****,Kiev,Ukraine
it is our great pleasure and privilege to invite you to Ambassador Plaza****,Kiev, Ukraine in April 2016 to take part in the International Pharmaceutical Manufacturing and Distribution-2015 exhibition and conference. International Society of GxP standards is planning exhibition in the beautiful place – Kiev,Ukraine.
International Pharmaceutical Manufacturing and Distribution-2016 premier European event for the latest updates and case studies on successfully ensuring the most efficient, traceable & secure pharmaceutical manufacturing and distribution networks.
Build stronger partnerships with your Pharma partners to get more insight. Ensure multi-enterprise interaction to achieve compliance and responsiveness
International Pharmaceutical Manufacturing and Distribution-2016 will offer delegates from pharma, specialty pharmacies, distributors, and PBMs the opportunity to engage in dialogue on ways to work together to effectively manage the distribution of existing products and new specialty pharmaceutical launches.
Within Pharmaceutical and Biotechnology manufacturing operations, maintaining a rigorous level of quality assurance is of the utmost importance. Outside of the strenuous and ever increasing FDA,EMEA and international regulatory standards, there is also the need to maintain the highest possible level of product quality. As corporations work to adapt to complex products, along with ever evolving regulatory guidance, learning from other organizations that have successfully grappled with these issues is of the utmost importance. This program will provide the pharmaceutical and biotechnology industries an open forum for discussion and debate amongst leading organizations on how to maintain the highest level of quality within manufacturing facilities.
Through addressing a wide variety of the challenges that quality assurance executives face in maintaining regulatory compliance within manufacturing facilities, this conference and Expo program will create a unique opportunity for networking and knowledge share for forward thinking pharmaceutical executives. Having an opportunity to discuss in an informal and private setting, the challenges in maintaining quality, and understanding what peer executives would do in particular situations will be of tremendous value to manufacturers and distributors in attendance.
Arguably the most important three letters concerning the pharmaceutical supply chain at present, the recent changes to the GDP guidelines have added to the pressure pile which rests on the shoulders of pharmaceutical supply chain and distribution experts.
The GDP developments concerning updated controlled temperature distribution, validation & qualification, and risk management requirements, all to be implemented within six months, have created a sense of urgency and panic in the pharma supply chain space. This is particularly relevant when you consider that the pharmaceutical supply chain is constantly looked at as an area where costs could and should be cut.
International Pharmaceutical Manufacturing Distribution-2016 event has been designed to uncover the buzz around the GDP guidelines, as well as tackling other essential pharmaceutical distribution challenges, including:
Implementing and integrating a central European distribution model
Sourcing the right logistics partners in marginal countries and emerging markets
Understanding and adopting the latest developments in track n’ trace and serialisation
New for 2016!
Get involved! With your choice of THREE NEW workshops offering you an in-depth and focused forum to discuss and discover more about the following topics:
The top 3 changes to the GDP guidelines this year: what are they and how can you implement them?
Successful End-to-End Supply Chain Management
Quality Management in Your Cold Supply Chain
Join us for the International Pharmaceutical Manufacturing and Distribution-2016 Meeting!
LIMITED SEATS ! REGISTRATION OPEN ON FIRST COME, FIRST SERVE BASIS
We are all really hoping you will find the city welcoming, the programme exciting, the company stimulating and the experience enriching. We look forward very much to welcoming you to Ukraine in April 2016 for the International Pharmaceutical Manufacturing and Distribution-2016
International Society of GxP standards
Why Exhibit at IPMD 2016?
Exhibitors reach high-level executives and influential decision makers who come to IPMD2016 to discover new players in the industry, form partnerships and evaluate technologies.
|Registration is required in orderto be admitted to the venue andfor participation in the program
of the Expo,Conference and
other IPMD 2016 activities.
Please click here for registration.
8:15 Registration & Networking Coffee
9:10 Chairman’s Opening Remarks
EXCLUSIVE FOCUS MORNING UNDERSTANDING AND ANALYSING THE LATEST REVISIONS TO THE GDP/GMP GUIDELINES
GDP/GMP guidelines finally released after several years in the drafting.
9:30 Exploring Specific Aspects of the Revised GDP/GMP Guidelines
10:10 Keeping Up With the EMA: controlled room temperature requirements
Exploring the current understanding of the GDP guidelines from the perspective of the pharmaceutical industry
First steps: analysing your current state of compliance to uncover the gaps
Successfully planning your actions of change and ensuring they are completed within the 6 month deadline
Considerations for future changes to the GDP regulations: how will they evolve?
10:50 Networking Coffee Break
11:10 Medicines Distribution in a New Regulatory Environment: the wholesaler perspective
Extended provisions governing medicines distribution through the introduction of new GDP guidelines
Who is concerned?
What has changed?
How does the sector cope?
- Continuous manufacturing and continuous improvement
- Aligning manufacturing with other functions to achieve operational excellence across the business
- Achieving a sustainable cultural change and engaging employees from shop floor to top floor
- Improve technology transfer efficiency to in-house and external manufacturing partners
INTERACTIVE PANEL DISCUSSION
11:50 GDP/GMP news.GENERICS
Our experts will join together to give different perspectives on the latest changes to the GDP guidelines.
12:20 Networking Lunch Break
13:20 Managing the Distribution Challenge in the Evolving Regulatory Environment
How do the EMA GDP guidelines and other regulatory changes alter the face of distribution in Europe and beyond?
What risks are associated with each transport mode – and how might you mitigate their impact?
How can multi-modal options benefit Pharma to improve the supply chain?
Where can improvements be made, including cost rationalisation, by using these guidelines to your advantage?
EXPLORING THE SUCCESSES AND CHALLENGES WITH VARIOUS DISTRIBUTION MODELS IN DIFFERENT MARKETS
14:00 Implementing and Integrating a Central European Distribution Model: a case study of trials and tribulations
Exploring the main challenges and the lessons to be learnt from building and setting up a centralised distribution hub in Europe
Analysing the difficulty with consolidating a pan-European distribution network into a more simplified and organised structure
Understanding how this distribution method can reduce fragmentation and increase leverage
14:40 Networking Coffee Break
IMPROVING THE EFFICIENCY AND QUALITY OF YOUR SUPPLY CHAIN
15:10 Moving Our Site from Push to Pull Planning/Operation with the Result of Cutting Inventories and Lead-times to Half: a case study
Understanding the strategies behind transforming your system from a push to a pull system in your site
Analysing how streamlining and making these changes can have an effect on your inventories and your lead-times
- Applying a risk-based approach to quality management
- Achieving compliance and meeting QA/QC standards
- Improving manufacturing control and decision making through effective data management
15:50 Interactive Quick Win Networking!
INTERACTIVE ROUNDTABLE DISCUSSIONS Crisis Management Sessions…
This is your chance to discuss key topics and challenges in smaller, interactive groups. You will be able to share your own experiences and hear from others, benchmark, exchange ideas and get clear answers to specific questions. So, in order to make the most of these interactive sessions, you should come armed and ready to share experiences and have questions at the ready!
8:30 Registration and Networking Coffee
9:30 Crisis Management Session
Unexpected challenges arise almost daily; here you will be split into subgroups and presented with a hypothetical crisis scenario. Spend time in your groups devising a strategy to keep your project on track. Each group will then feedback their strategy and a compare and contrast discussion will take place – is there a one size fits all answer?
Manufacturing: Outsourcing and contract manufacturing:
- Building and maintaining a network of vetted business partners
- Opening channels of communication between organizations
- Securing the supply chain through sourcing strategies and contingency planning
SECURITY, TRACEABILITY AND SUPPLY CHAIN INTEGRITY
10:00 Understanding the Product Authentication System and its Applicability to Europe
The current challenges relating to detecting counterfeit drugs in the supply chain
The benefits and pitfalls of online and on-site authentication
Keeping abreast of the latest technological, legislative and sector-agreed developments in a rapidly evolving landscape
10:40 Networking Coffee Break
11:10 GS1 Standards: how are they relevant to your supply chain?
Successfully unveil better visibility internally as well as with your business partners by synchronising data
Analysing the emerging and existing requirements in various countries to ensure the success of your international distribution strategy
Enabling regulatory compliance for increased traceability
Manufacturing: Emerging markets:
- Driving growth through developing a manufacturing presence in emerging markets
- Understanding the challenges and opportunities to pharmaceutical companies in the developing world
- Creating a mutually beneficial relationship with local regulators and domestic industry players
- Overcoming cultural and regulatory barriers of manufacturing in new locations
11:50 Speed Networking
Like Speed Dating, But Without the Pressure to Commit
You’ve seen each other across the room…now meet face-to-face.
Bring plenty of business cards to exchange in a series of 2-3 minute one-on-one meetings with your fellow speakers, attendees and vendors.
Your mission – learn one of the following things about each person you meet:
What do you understand of the new EMA GDP updates?
What have you been doing to put the updates into effect?
What has been your biggest challenge when looking at new ambient temperature requirements?
12:20 Networking Lunch
13:20 Getting the Best Value from Serialisation and Anti-Counterfeiting Investments
Tuning your processes: internally and at external service providers
Choosing technologies: finding partners who add value not cost
Combining security, efficiency, engagement, adherence, mobile health and pharmacovigilance
Moving from “must-do” compliance to seizing a “must-not-miss” opportunity
INTERACTIVE PANEL DISCUSSION
14:00 Centalisation vs. Decentralisation
The facilitator will encourage participants to give their perspectives on the issue of centralisation vs. decentralisation.
Examples of the successes of centralising your distribution networks
Examining the advantages and disadvantages of both methods
Understanding how to strategically plan and carry out centralisation
14:30 Networking Coffee Break
ANALYSING THE MORE CHALLENGING AND RARE DISTRIBUTION PROBLEMS
15:00 Challenges in the Distribution of Short-LivedPharmaceuticals
How do regulations impact the availability of pharmaceuticals to patients?
Do the (new) GDP guidelines “understand” pharmaceuticals?
How do we handle transport and storage conditions?
Logistics and Distribution Leader
15:40 Speaker Clinic – Your Questions Answered!
16:15 Chairman’s Closing Summary and Close of Conference
Ambassador Plaza hotel,
Marshala Hrechka street, 5, Kyiv,Ukraine
February 15, 2016
International Society of GxP standards
11 rue Pierre et Marie Curie
Paris, France 75231