| Issue |
Topic |
Ad Closing Dates |
Camera-Ready Date |
| January |
EMEA-FDA Joint Ventures
This issue will review existing and planned joint ventures between EMEA and FDA on product lifecycle. Article submission deadline 15 October 2008 |
11 November 2008 |
18 November 2008 |
| February |
Doing Business in Asia
This issue will discuss the business environment, culture, government and politics of doing business in Asia. It will include issues to be considered in strategic planning, licensing and partnerships. Article submission deadline 15 November 2008. |
12 December 2008 |
19 December 2008 |
| March |
Role and Function of Regulatory
Role and Function of Regulatory This issue will examine how regulatory works with clinical, manufacturing, quality and other cross-functional areas. It also will address interactions with health authorities and other external organizations. Article submission deadline 15 December 2008. |
16 January 2009 |
23 January 2009 |
| April |
Regulatory Career Progression
This issue will explore all aspects of regulatory functions across product lines and professional levels, as well as progression through the regulatory career framework. Article submission deadline 15 January 2009. |
13 February 2009 |
20 February 2009 |
| May |
Update on FDAAA
This issue will examine FDA's progress in implementing key provisions of FDAAA. It also will review what industry has done to prepare for agency reforms. Article submission deadline 15 February 2009. |
13 March 2009 |
20 March 2009 |
| June |
Clinical Trials
This issue will provide an update on the latest trends in clinical trial design and the conduct of trials worldwide. Article submission deadline 15 March 2009. |
17 April 2009 |
24 April 2009 |
| July |
Due Diligence
This issue will examine regulatory's role in due diligence. It will also discuss how to prepare for and conduct due diligence activities. Article submission deadline 15 April 2009. |
15 May 2009 |
22 May 2009 |
| August |
Botanical Products
This issue will provide an in-depth look at botanical products, including global regulations and intellectual property issues. Article submission deadline 15 May 2009. |
12 June 2009 |
19 June 2009 |
| September |
Postmarketing Compliance Activities
This issue will address postapproval regulatory activities, including lifecycle management, safety issues and inspections. Article submission deadline 15 June 2009. |
17 July 2009 |
24 July 2009 |
| October |
Drug Approval Pathways
This issue will explore aspects of innovator products and follow on products including Hatch Waxman and 505(b)(2) applications. It will cover such topics as patent protections, means for obtaining additional marketing exclusivity, the impact of generic product entry and the impact on pricing. The issue will cover and intellectual property considerations. Article submission deadline 15 July 2009. |
14 August 2009 |
21 August 2009 |
| November |
Advertising, Labeling & Promotion
This issue will provide an update on ongoing activities, including internal review processes, label negotiations and DTC advertising. Article submission deadline 15 August 2009. |
11 September 2009 |
18 September 2009 |
| December |
Risk-Benefit Analysis
This issue will examine the implications of risk-benefit analysis approaches among regions. This will include articles on both drugs and devices. Article submission deadline 15 September 2009. |
16 October 2009 |
23 October 2009 |