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is a division of
Managing Legal Risks In Pharmaceutical Manufacturing Outsourcing
Summary
18 Nov 2008-19 Nov 2008 — The Union League, Philadelphia, PA, USA
American Conference Institute's Managing Legal Risks in Pharmaceutical Manufacturing Outsourcing brings together government officials, in-house counsel from major pharmaceutical companies, and expert outside counsel who will guide you through the painstaking but necessary process of ensuring that your contracts are drafted, negotiated, and executed in the most favorable and protective manner.
Contact details
email: CustomerService@AmericanConference.com phone: +1 888 224 2480
Booking
| $1895 to $2795 |
Venue
The Union League, 140 South Broad Street, Philadelphia, USA.
Conference — 18 Nov Tue-12:00 19 Nov 2008
A strong manufacturing agreement is no longer sufficient to protect the company against catastrophe, which may include massive recalls, costly litigation, and misappropriation of intellectual property. The key is to think about every potential outcome at the drafting and negotiation phase and make sure that your intentions behind the underlying contract are executed through out the term. Along with the FDA's increased scrutiny over U.S. and overseas manufacturing plants, quality control within the company must be completely reassessed from the ground up.
Register your place here
Monday, November 17, 2008
1:00 - 4:00 p.m. (Registration begins at 12:30 p.m.)
Pre-Conference Master Class
(includes 1 credit hour of CLE Ethics)
The "Win-Win" Pharmaceutical Manufacturing Outsourcing Agreement: Practical and Ethical Drafting and Negotiating Strategies
Tuesday, November 18, 2008
8:15 Co-Chairs' Opening Remarks
8:30 KEYNOTE PRESENTATION
9:30 Implementing Procedures and Safeguards to Manage a Recall as the Result of a Manufacturing Defect
10:45 Coffee Break
11:00 Ensuring Manufacturers Stay Within Regulatory Parameters to Avoid Government Scrutiny, Sanctions, and Multiple FDA Inspections
12:30 Networking Luncheon for Speakers and Delegates
1:15 Ensuring that the Manufacturer Operates in Accordance With GMPs and FDA Mandates
2:30 Incorporating Audit Rights into the Contract to Ensure Maintenance of Quality, Performance, and Protection of IP
3:30 Refreshment Break
3:45 Assessing and Balancing Risks and Benefits When Contracting With CMOs
5:00 Conference Adjourns
Day Two: Wednesday, November 19, 2008
8:45 Co-Chairs' Opening Remarks
9:00 Minimizing the Risk of Violating International Laws, Rules, and Regulations
10:00 Coffee Break
10:15 Going Beyond Standard Contractual Language to Ensure That the Manufacturer Will Maintain Your Confidentiality
11:15 Avoiding the Courts: Negotiating Different Means of Alternative Dispute Resolution for Pharmaceutical Companies
12:15 Networking Luncheon for Speakers and Delegates
1:30 Indemnification and Insurance: Allocating Risks and Liabilities Among the Parties Involved in the Pharmaceutical Outsourcing Agreement
2:45 Refreshment Break
3:00 Ensuring that the Damages and Recovery Provisions Will Protect the Company in the Event of a Contractual Violation
4:30 Conference Concludes
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